Welcome to the M Lab™ Collaboration Centers – where customers can use non-GMP lab spaces to operate equipment, evaluate processes and receive real-time technical support without disrupting production.
Plan your visit: www.merckmillipore.com/mlab
Viral Risk Mitigation - A Global Regulatory PerspectiveMilliporeSigma
Looking for insights into current global regulatory expectations for viral safety? Read the special report from BioProcess International, in collaboration with Martin Wisher, Senior Regulatory Consultant focusing on BioReliance biosafety® services.
Welcome to the M Lab™ Collaboration Centers – where customers can use non-GMP lab spaces to operate equipment, evaluate processes and receive real-time technical support without disrupting production.
Plan your visit: www.merckmillipore.com/mlab
For an unparalleled experience throughout the life cycle of your therapy, BioReliance® world-class biosafety solutions offer a full range of GMP cell banking services, cell line and virus bank characterization, viral clearance and lot release testing. Merck’s complete biosafety testing solutions, paired with our long-standing reputation for quality and expertise, will give you the mission-critical capabilities to bring safe, life-changing medicines to market.
Strategies for Effective Bioburden and Aseptic ControlMilliporeSigma
For an unparalleled experience throughout the life cycle of your therapy, BioReliance® world-class biosafety solutions offer a full range of GMP cell banking services, cell line and virus bank characterization, viral clearance and lot release testing. MilliporeSigma’s complete biosafety testing solutions, paired with our long-standing reputation for quality and expertise, will give you the mission-critical capabilities to bring safe, life-changing medicines to market.
This document provides an overview of global regulatory guidance for ensuring viral safety in biologics production. It discusses three key approaches: preventing contamination through high quality raw materials; detecting contamination through testing cell banks, raw materials, and process intermediates; and evaluating viral clearance in the production process. The summary discusses the types of regulatory documents that provide guidelines on raw materials and cell lines, as well as strategies for preventing contamination, detecting contamination through a variety of assay methods, and limitations of detection assays.
Webinar: How Biosafety Testing will Evolve to Meet the Needs of Biologics Man...MilliporeSigma
Are you ready to accelerate biosafety testing?
The pressure to shorten delivery times and reduce costs for biologics such as mAbs are driving an evolution in the biomanufacturing space. Ironically, where we see almost daily innovation in production technologies, many of the methods used for biosafety testing are decades old. These traditional testing methods are often culture based and can take several weeks to produce the required result to allow for batch release. In this talk we will explore how new methods can be used to accelerate biosafety testing today, as well as how they can evolve to meet new manufacturing paradigms such as continuous processing and novel cell and gene therapy treatment modalities.
Participate in the interactive webinar now: http://bit.ly/BlazarWebinar
Explore our webinar library: www.emdmillipore.com/webinars
Latest Updates in Biosafety Testing for Gene TherapyMilliporeSigma
The document discusses the latest regulatory expectations and challenges for biosafety testing of gene therapies, including how to design a robust safety testing strategy to test for bacteria, fungi, mycoplasma, endotoxins, and adventitious viruses using methods such as sterility testing, PCR assays, and in vivo and in vitro testing. It also covers emerging areas like next generation sequencing, replication competent AAV detection, and characterization of residual DNA levels.
TetraQ is a preclinical drug development facility located at the University of Queensland in Brisbane, Australia. It was founded in 2005 by four experts in the core areas of preclinical drug development - efficacy, ADME, toxicology, and pharmaceutics. TetraQ provides a range of preclinical services including efficacy testing in disease models, ADME/pharmacokinetic studies, toxicology testing, and formulation development to assess drug candidates and help reduce risks prior to clinical trials. The services help determine whether drug candidates are likely to be safe and effective enough to advance to human studies.
Viral Risk Mitigation - A Global Regulatory PerspectiveMilliporeSigma
Looking for insights into current global regulatory expectations for viral safety? Read the special report from BioProcess International, in collaboration with Martin Wisher, Senior Regulatory Consultant focusing on BioReliance biosafety® services.
Welcome to the M Lab™ Collaboration Centers – where customers can use non-GMP lab spaces to operate equipment, evaluate processes and receive real-time technical support without disrupting production.
Plan your visit: www.merckmillipore.com/mlab
For an unparalleled experience throughout the life cycle of your therapy, BioReliance® world-class biosafety solutions offer a full range of GMP cell banking services, cell line and virus bank characterization, viral clearance and lot release testing. Merck’s complete biosafety testing solutions, paired with our long-standing reputation for quality and expertise, will give you the mission-critical capabilities to bring safe, life-changing medicines to market.
Strategies for Effective Bioburden and Aseptic ControlMilliporeSigma
For an unparalleled experience throughout the life cycle of your therapy, BioReliance® world-class biosafety solutions offer a full range of GMP cell banking services, cell line and virus bank characterization, viral clearance and lot release testing. MilliporeSigma’s complete biosafety testing solutions, paired with our long-standing reputation for quality and expertise, will give you the mission-critical capabilities to bring safe, life-changing medicines to market.
This document provides an overview of global regulatory guidance for ensuring viral safety in biologics production. It discusses three key approaches: preventing contamination through high quality raw materials; detecting contamination through testing cell banks, raw materials, and process intermediates; and evaluating viral clearance in the production process. The summary discusses the types of regulatory documents that provide guidelines on raw materials and cell lines, as well as strategies for preventing contamination, detecting contamination through a variety of assay methods, and limitations of detection assays.
Webinar: How Biosafety Testing will Evolve to Meet the Needs of Biologics Man...MilliporeSigma
Are you ready to accelerate biosafety testing?
The pressure to shorten delivery times and reduce costs for biologics such as mAbs are driving an evolution in the biomanufacturing space. Ironically, where we see almost daily innovation in production technologies, many of the methods used for biosafety testing are decades old. These traditional testing methods are often culture based and can take several weeks to produce the required result to allow for batch release. In this talk we will explore how new methods can be used to accelerate biosafety testing today, as well as how they can evolve to meet new manufacturing paradigms such as continuous processing and novel cell and gene therapy treatment modalities.
Participate in the interactive webinar now: http://bit.ly/BlazarWebinar
Explore our webinar library: www.emdmillipore.com/webinars
Latest Updates in Biosafety Testing for Gene TherapyMilliporeSigma
The document discusses the latest regulatory expectations and challenges for biosafety testing of gene therapies, including how to design a robust safety testing strategy to test for bacteria, fungi, mycoplasma, endotoxins, and adventitious viruses using methods such as sterility testing, PCR assays, and in vivo and in vitro testing. It also covers emerging areas like next generation sequencing, replication competent AAV detection, and characterization of residual DNA levels.
TetraQ is a preclinical drug development facility located at the University of Queensland in Brisbane, Australia. It was founded in 2005 by four experts in the core areas of preclinical drug development - efficacy, ADME, toxicology, and pharmaceutics. TetraQ provides a range of preclinical services including efficacy testing in disease models, ADME/pharmacokinetic studies, toxicology testing, and formulation development to assess drug candidates and help reduce risks prior to clinical trials. The services help determine whether drug candidates are likely to be safe and effective enough to advance to human studies.
An ever-evolving regulatory environment makes navigating gene therapy products through to clinic much more complicated than a traditional biologic. While manufacturing platforms and regulatory requirements for testing of antibodies has existed for decades, gene therapy platforms and their testing requirements are changing rapidly with the progression of products toward commercialization.
See the Whole Picture: Using SV-AUC for Empty/Full AAV Capsid AnalysisMilliporeSigma
Watch this webinar here: https://bit.ly/31ZZM3n
Join this webinar for key insights on using the SV-AUC assay for empty/full analysis of your AAV viral vector. We’ll cover the technical requirements for this assay, data interpretation, and finally how this assay fits into the larger picture of AAV characterization.
Recombinant adeno-associated viruses (AAV) are widely used as gene transfer vectors. However, AAV production generates mixed populations of viral capsids containing either complete viral vector genome (full capsids); partially filled, and those lacking the viral genome (empty capsids). Sedimentation Velocity Analytical Ultracentrifugation (SV-AUC) offers a robust, accurate, and consistent method for characterizing empty/full AAV capsid composition. In this webinar we will review the key technical requirements for performing an AUC assay as well as analysis and data interpretation of the results generated.
In this webinar, you will learn:
• Regulatory expectations for empty/full analysis
• Key technical requirements for running an AUC assay and how to interpret the data from the results generated
• How the AUC assay fits into the larger picture of AAV characterization
An Integrated Approach to Ensure Viral Vector and Gene Therapy Commercial Rea...MilliporeSigma
This document discusses an integrated approach to ensuring viral vector and gene therapy commercial readiness. It covers four main topics: 1) the current state and future perspectives of viral vectors, 2) scalability and reproducibility in viral vector manufacturing, 3) testing and quality considerations, and 4) regulatory approval and commercial readiness. The current demand for clinical and commercial doses of viral vectors is increasing. Ensuring scalable, reproducible manufacturing processes and comprehensive testing and quality measures is critical for regulatory approval and commercialization.
Sartorius offers a wide range of bioreactor and fermentation solutions for cell culture and microbial production processes. This includes mini bioreactors, benchtop bioreactors, stainless steel bioreactors, and single-use bioreactors ranging in size from 10 mL to 2,000 L. Sartorius' portfolio includes automated systems, single-use and glass vessels, and controllers to support applications from early research to large-scale production.
Promises and Challenges of Manufacturing and Testing Viral Producer Cell LinesMerck Life Sciences
To date, manufacturing of lentivirus (LV) vectors for gene therapy commonly relies on transient transfection of adherent HEK293 cells. This method is costly, time-consuming, difficult to scale-up and poorly reproducible, rendering large-scale applicability to fulfill increasing demand of LV in clinical pipelines cumbersome. The use of suspension-adapted transient producer cell lines for LV production has overcome some of these challenges. Furthermore, successful creation of stable producer cell lines would allow creation of master and working cell banks easily amenable to commercial production. The ideal producer cell lines should demonstrate stability in growth and gene expression, and be easily adaptable to chemically defined culture conditions and optimized for high-titer virus production. The availability of more robust producer cell lines thus represents an important scalable first step towards manufacturing processes that are conducive to large-scale production. Ultimately, these producer cell lines must be screened to satisfy various biosafety and regulatory implications.
In this webinar, you will learn:
• Process development for transient and stable producer cell lines
• Screening of cellular gene targets via CRISPR to improve LV production from producer cell lines
• cGMP and Regulatory readiness: Cell line characterization and release testing through BioReliance® global service offering
Process Impurities: Don’t Let PEI or HCP Derail Your BioTherapyMerck Life Sciences
View our webinar here: https://bit.ly/2lKNdWX
Many different impurities are present in or generated during biotherapy manufacturing. This webinar will address how process contaminates can arise from raw input materials, occur as residual processing agents, or form as reaction by-products. We will review strategies within product characterization to de-risk the manufacturing process, including the use of routine and high complexity assays; and the recommended testing to meet regulatory requirements for clinical submission. Learn methods to avoid costly pitfalls and implement procedures to expedite product quality decisions at critical junctures in your development plan. We will discuss two types of therapies:
Cell & Gene Therapies
Polyethylenimine (PEI) is a transfection agent used in nearly all cell and gene therapy products. We will review the regulations and the liquid chromatography with charged aerosol detection (LC-CAD) methodology to demonstrate PEI removal during the production process.
Monoclonal Antibodies (mAb) and Cell & Gene Therapies
During mAb manufacturing and inherent to Cell & Gene Therapies, a significant proportion of process impurities arise from the host cell used to express the drug. Host cell protein (HCP) impurities, present at PPM-levels, are a major immunogenicity risk because they can elicit an unpredictable immune response in patients. We will review why their complex and diverse nature makes them challenging to monitor, and theho best practices, specifically HCP identification by mass spectrometry, for detection.
Learning points:
1. Accurate detection and characterization of residual PEI in cell and gene therapy products
2. Effective detection and characterization of residual host cell proteins (HCP) in mAbs
3. Available technology and assays for quantifying process impurities
4. Current regulatory requirements for detecting, quantifying, and removing process impurities during biotherapy manufacturing
Keeping the (Adventitious) Virus Out of the (Adeno-Associated) VirusMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/2VRylbi
How can you keep an adventitious virus from contaminating your gene therapy that is delivered by an adeno virus vector? As viral vector bioprocessing advances, regulatory requirements for viral safety will as well. Learn how to define your viral clearance strategy for AAV delivered gene therapies.
How do you define a strategy for viral clearance for a process that inherently aims at purifying a virus?
Gene delivery using AAV has received a boost from two major approvals and the nearly 300 programs in the clinic. Novel gene therapies using viral vectors enable companies to transform the lives of people living with certain rare and ultra-rare diseases where treatments are often not available currently. Amongst a multitude of challenges in viral vector bioprocessing, uncertainty in regulatory expectations is a major challenge to gene therapy developers. Regulatory requirements are evolving as the science and manufacturing matures with more stringent measures for viral safety assurance expected for future approvals.
Learn how to implement techniques for adventitious virus removal in your viral vector process; we will focus on strategies for viral clearance along your journey towards commercial readiness of AAV-based processes.
In this webinar, you will learn:
• AAV process flows and focus areas for viral safety
• Strategies for implementing viral clearance measures in bioprocessing
• Case studies and data driven approaches on log reduction values (LRV) in a viral vector process
• Best practices and evaluation roadmaps on conducting viral clearance studies
Presented by: Ratish Krishnan, Senior Strategy Consultant, Novel Modalities Bioprocessing
Upcoming USP 665 - Level of Characterization of Single-Use Systems Today and ...MilliporeSigma
Register for the interactive, on-demand webinar now: https://bit.ly/USP665
Single-use plastic systems are being utilized more frequently especially for COVID-19 vaccine manufacturing. However, there are issues regarding standardization of quality information that limits implementation efficiencies. One of the challenges is the evaluation of leachables derived from a variety of different plastic components in a timely manner.
Since the USP <665> highlights a risk assessment approach with no typical pass/fail limit, approaches to decision-making based on the extractables data package will be reviewed. In addition, we will highlight legacy testing requirements which may not be necessary once USP <665> is implemented.
In this webinar, we will discuss:
- Regulatory expectations of extractables and leachables assessment today and tomorrow
- The right criteria that need to be assessed to select the type and quality of plastic materials for use in biopharmaceutical manufacturing
Upstream Viral Safety: A Holistic Approach to Mitigating Contamination RisksMilliporeSigma
The document discusses strategies for mitigating viral contamination risks in upstream biomanufacturing processes. It outlines a holistic approach involving careful selection and testing of raw materials, risk analysis to identify high-risk components, and various mitigation technologies like gamma irradiation, HTST pasteurization, and virus retentive filtration. Virus retentive filters designed specifically for cell culture media can provide over 4 logs of viral reduction while maintaining media performance. Combined with other controls, these strategies aim to prevent viral contamination upstream and reduce risks of disruption to operations.
Accelerating COVID-19 Therapies: How a streamlined biosafety strategy can get...Merck Life Sciences
Access the interactive recording: https://bit.ly/2xB2eRs
Abstract:
Vaccine and other biologic developers have long relied on traditional, growth-based methods for the detection of adventitious agents in a biosafety testing package. However, at a time where speed is of the essence, relying on testing methods that take many weeks is a real concern. Fortunately, alternative rapid detection methods can shorten timelines significantly — especially for Phase I testing. Here we will take you through these rapid alternatives and outline a testing strategy that can bring your therapy to the clinic faster.
Process Development for Cell Therapy and Viral Gene TherapyMerck Life Sciences
Today’s viral vector manufacturing processes remain challenging. Process development is a critical enabler to bring safe, effective, sustainable products to market to address patient needs. When done properly, it can reduce the timeline of the project and the cost of producing the therapeutic product.
The webinar discusses our strategies for developing lentivirus and adeno associated virus (AAV) and the impact these early decisions can have on commercial readiness.
Watch the interactive webinar now: https://bit.ly/2VplwQq
Biopharma Production and Development China 2015 Rita Barry
As the BioPharma industry grows in China and the Asian region, we invite you to be a part of this tremendous growth & development opportunities!
IBC’s Biopharma Development & Production Week in China is THE meeting place for biopharma industry professionals and scientists to get the highest quality and practical information that will enable them to develop competitive advantages and advance their capabilities in developing and manufacturing cell lines, biosimilars, biobetters, vaccines or novel biologics.
Top Reasons Why You Should Participate:
- Establish Business Partnerships with Chinese/Asian drug developers and contract
manufacturers
- Learn technical & practical know how from experiences on the ground in Asia
- Showcase your cutting edge solutions in front of key China/Asian Biopharma
decision makers
http://www.biopharmaproduction.com
In this webinar, you will learn:
Sources of endotoxin contamination
Contamination control strategy
Endotoxin removal strategies
Detailed description:
Endotoxin, a lipopolysaccharide (LPS), is a type of pyrogen and is a component of the exterior cell wall of Gram-negative bacteria. To ensure safety on patient’s endotoxin content in the drug should always be controlled. In a biological processing it may emanate from facility, utility, raw materials, process, and personnel. In this webinar we discuss the regulatory norms, strategies for prevention & removal of endotoxin to ensure that the final drug product is safe.
Aseptic Process Sampling to address Risk of Contamination & Containment in co...MilliporeSigma
Watch this webinar here: bit.ly/asepticwebinar2020
In this webinar, you will learn:
- The challenges tied to contamination control within a biopharmaceutical environment.
- What closed processing is, and how sampling solutions are an integral component towards that end.
- Advantages of sterile sampling from both a technical and economical viewpoint; with the review of a technical study confirming contamination risk reduction and total cost of ownership.
- Recommendations and requirements stated by these major regulatory authorities around the monitoring of the manufacturing process with the execution of sampling.
Detailed description:
Biopharmaceutical manufacturers are required to ensure drug product quality attributes for patient safety. Strong contamination control strategies should be considered early in process design, and have direct influence on the production environment and equipment selection.
Sampling at each step is a critical component in maintaining a contamination control strategy. Regulators are critical in the sampling process, as it predicts the state of the product or process, and needs to be Representative. A case study will be presented that demonstrates a closed, robust sampling solution capable of maintaining a sterile flow path when challenged with Brevundimonas diminuta. The sampling option you select can help support your goal in achieving a closed process, improving your risk mitigation strategy and product safety.
Excipients selection for high risk formulations Smita RajputMerck Life Sciences
Are you choosing the right excipients for your high risk application? Find out how to select the right excipients and enable your process optimization to improve the total cost of ownership.
In this webinar, you will learn:
• Selection of right excipients for high risk formulation is very critical step
• Low Endotoxin and low bioburden limits are important aspect while selecting raw materials
• Strong regulatory support is crucial for high risk formulation
Excipients selection for high risk formulations like parenteral and ophthalmic applications is very challenging. Excipients should be inert with high purity for such dosage forms because trace amounts of impurities present in excipients can interact with active pharmaceutical ingredient (API) which results in instability of the formulation. This presentation discusses how to select the right excipients for high-risk applications and gives guidance for process optimization by choosing the best combination of filters and excipients to improve the total cost of ownership.
Employing Innovative Platform Manufacturing and Biosafety Testing for your Ge...MilliporeSigma
Watch the webinar here: https://event.on24.com/wcc/r/2003970/F5AFA4FE6C60AD00635D4D15BADB5D8E?partnerref=slideshare
As gene therapies and gene-modified cell therapies show increasing promise, the need for innovative and proficient viral vector manufacturing continues to grow. Concurrently, increased regulatory guidance governing the manufacturing and testing of viral vectors adds complexity and increases the timelines to successfully produce high-quality virus ready for clinical use.
This webinar will address how the implementation of both manufacturing templates and platform characterization and safety assays can increase the likelihood of success in process validation and reduce risk in the timeline to commercialization for your gene therapy product. Using adeno-associated virus (AAV) as a case study, we will demonstrate how our validated, templated process for production can reduce the need for qualification inherent in niche manufacturing workflows and anticipate forthcoming needs for process performance qualification. This webinar will also highlight benefits from a new, platform assay offering for characterization and safety testing of AAV. Because these assays are pre-qualified, they reduce the variability inherent in assay validation and subsequently the time needed to establish readiness for regulatory compliance.
While these developments increase the standardization across the manufacturing and testing workflows, they remain flexible to clients' needs and are created to be scalable and as future-proof as possible, allowing for adaptability as the regulatory landscape of gene therapies evolves.
In this webinar, you will learn:
● The unit operations in AAV manufacturing that are ideal for templating
● How the manufacturing workflow can be targeted to reduce variability in testing and improve readiness for commercial production
● How platform assays can ease the burden of assay qualification and improve overall commercialization timelines
Rapid Methodologies for Biosafety Testing of Biologic TherapeuticsMerck Life Sciences
Learn about existing and emerging methods to accelerate biosafety testing of biologic therapies.
Speed to market for biologic therapeutics is ever more critical. However, the critical safety tests for these molecules, for example screening for adventitious agents such as viral contaminants, can be time consuming as well as challenging and laborious. Join us for this webinar as we explore how rapid methodologies are being used to not only accelerate this process, but also enhance quality by reducing testing complexity. Existing technologies as well as emerging trends will be discussed, along with the implications these may have on the regulatory landscape.
In this webinar you will learn:
● Which existing and emerging technologies are having now, and will have in the future, an impact on biosaftey testing.
● The benefits as well as risks of employing rapid methods for biosafety screening.
● How the regulatory agencies are reacting to rapid testing methods as alternatives to existing methods.
This document summarizes PCT's vision and history as a leader in cell therapy manufacturing. PCT aims to make transformative cell-based therapies accessible to all through providing high-quality and scalable manufacturing services. Over 30 years, PCT has gained unprecedented expertise manufacturing over 20 cell therapy products and treating over 6,000 patients. PCT partners with companies from start-ups to large pharmaceutical companies, and aims to guide clients through the entire development and manufacturing process.
This document provides information about the Cell & Gene Therapy conference taking place on October 10-11, 2018 in London. It includes details about the agenda, speakers, workshops, and registration information. The two-day conference will focus on topics related to manufacturing, regulation, and translational research of cell and gene therapies. There will be presentations from industry experts on developing stem cell and gene therapies, as well as workshops on practical development issues and competitive intelligence in the cell and gene therapy field.
One of the hottest topics in the biopharmaceutical industry today is “continuous bioprocessing”. Buzzwords such as “process intensification”, “next generation bioprocessing”, “process optimization”, and “integrated, connected manufacturing” are prevalent in industry conference programs and biopharma trade publications. This is no surprise considering that by 2025, it is expected that 20 percent of revenue from molecules that are still in the pipeline today will come from drugs manufactured with next generation technologies. It is estimated that roughly 35 percent of today’s commercial molecules will utilize process intensification methods within the next 5-10 years.
But what actually is next generation bioprocessing? How are industry players defining next generation bioprocessing and how will they pursue and successfully implement this approach? And is continuous bioprocessing always the ultimate end goal drug manufacturers around the globe are, or should be, striving for?
In this dedicated supplement, experts from both biologics manufacturers and from Merck provide their insights and perspectives on the on-going paradigm shift towards next generation bioprocessing occurring in today’s and tomorrow’s biopharma landscape.
“The Most Recommended Pharma & Life Sciences Solution providers in 2021” highlighting the pharmaceutical and healthcare industries help to improving the human health and forwarding life-expectancy one step further.
The Future of Bioprocessing – What you need to know.MilliporeSigma
One of the hottest topics in the biopharmaceutical industry today is “continuous bioprocessing”. Buzzwords such as “process intensification”, “next generation bioprocessing”, “process optimization”, and “integrated, connected manufacturing” are prevalent in industry conference programs and biopharma trade publications. This is no surprise considering that by 2025, it is expected that 20 percent of revenue from molecules that are still in the pipeline today will come from drugs manufactured with next generation technologies. It is estimated that roughly 35 percent of today’s commercial molecules will utilize process intensification methods within the next 5-10 years.
But what actually is next generation bioprocessing? How are industry players defining next generation bioprocessing and how will they pursue and successfully implement this approach? And is continuous bioprocessing always the ultimate end goal drug manufacturers around the globe are, or should be, striving for?
In this dedicated supplement, experts from both biologics manufacturers and from MilliporeSigma provide their insights and perspectives on the on-going paradigm shift towards next generation bioprocessing occurring in today’s and tomorrow’s biopharma landscape.
An ever-evolving regulatory environment makes navigating gene therapy products through to clinic much more complicated than a traditional biologic. While manufacturing platforms and regulatory requirements for testing of antibodies has existed for decades, gene therapy platforms and their testing requirements are changing rapidly with the progression of products toward commercialization.
See the Whole Picture: Using SV-AUC for Empty/Full AAV Capsid AnalysisMilliporeSigma
Watch this webinar here: https://bit.ly/31ZZM3n
Join this webinar for key insights on using the SV-AUC assay for empty/full analysis of your AAV viral vector. We’ll cover the technical requirements for this assay, data interpretation, and finally how this assay fits into the larger picture of AAV characterization.
Recombinant adeno-associated viruses (AAV) are widely used as gene transfer vectors. However, AAV production generates mixed populations of viral capsids containing either complete viral vector genome (full capsids); partially filled, and those lacking the viral genome (empty capsids). Sedimentation Velocity Analytical Ultracentrifugation (SV-AUC) offers a robust, accurate, and consistent method for characterizing empty/full AAV capsid composition. In this webinar we will review the key technical requirements for performing an AUC assay as well as analysis and data interpretation of the results generated.
In this webinar, you will learn:
• Regulatory expectations for empty/full analysis
• Key technical requirements for running an AUC assay and how to interpret the data from the results generated
• How the AUC assay fits into the larger picture of AAV characterization
An Integrated Approach to Ensure Viral Vector and Gene Therapy Commercial Rea...MilliporeSigma
This document discusses an integrated approach to ensuring viral vector and gene therapy commercial readiness. It covers four main topics: 1) the current state and future perspectives of viral vectors, 2) scalability and reproducibility in viral vector manufacturing, 3) testing and quality considerations, and 4) regulatory approval and commercial readiness. The current demand for clinical and commercial doses of viral vectors is increasing. Ensuring scalable, reproducible manufacturing processes and comprehensive testing and quality measures is critical for regulatory approval and commercialization.
Sartorius offers a wide range of bioreactor and fermentation solutions for cell culture and microbial production processes. This includes mini bioreactors, benchtop bioreactors, stainless steel bioreactors, and single-use bioreactors ranging in size from 10 mL to 2,000 L. Sartorius' portfolio includes automated systems, single-use and glass vessels, and controllers to support applications from early research to large-scale production.
Promises and Challenges of Manufacturing and Testing Viral Producer Cell LinesMerck Life Sciences
To date, manufacturing of lentivirus (LV) vectors for gene therapy commonly relies on transient transfection of adherent HEK293 cells. This method is costly, time-consuming, difficult to scale-up and poorly reproducible, rendering large-scale applicability to fulfill increasing demand of LV in clinical pipelines cumbersome. The use of suspension-adapted transient producer cell lines for LV production has overcome some of these challenges. Furthermore, successful creation of stable producer cell lines would allow creation of master and working cell banks easily amenable to commercial production. The ideal producer cell lines should demonstrate stability in growth and gene expression, and be easily adaptable to chemically defined culture conditions and optimized for high-titer virus production. The availability of more robust producer cell lines thus represents an important scalable first step towards manufacturing processes that are conducive to large-scale production. Ultimately, these producer cell lines must be screened to satisfy various biosafety and regulatory implications.
In this webinar, you will learn:
• Process development for transient and stable producer cell lines
• Screening of cellular gene targets via CRISPR to improve LV production from producer cell lines
• cGMP and Regulatory readiness: Cell line characterization and release testing through BioReliance® global service offering
Process Impurities: Don’t Let PEI or HCP Derail Your BioTherapyMerck Life Sciences
View our webinar here: https://bit.ly/2lKNdWX
Many different impurities are present in or generated during biotherapy manufacturing. This webinar will address how process contaminates can arise from raw input materials, occur as residual processing agents, or form as reaction by-products. We will review strategies within product characterization to de-risk the manufacturing process, including the use of routine and high complexity assays; and the recommended testing to meet regulatory requirements for clinical submission. Learn methods to avoid costly pitfalls and implement procedures to expedite product quality decisions at critical junctures in your development plan. We will discuss two types of therapies:
Cell & Gene Therapies
Polyethylenimine (PEI) is a transfection agent used in nearly all cell and gene therapy products. We will review the regulations and the liquid chromatography with charged aerosol detection (LC-CAD) methodology to demonstrate PEI removal during the production process.
Monoclonal Antibodies (mAb) and Cell & Gene Therapies
During mAb manufacturing and inherent to Cell & Gene Therapies, a significant proportion of process impurities arise from the host cell used to express the drug. Host cell protein (HCP) impurities, present at PPM-levels, are a major immunogenicity risk because they can elicit an unpredictable immune response in patients. We will review why their complex and diverse nature makes them challenging to monitor, and theho best practices, specifically HCP identification by mass spectrometry, for detection.
Learning points:
1. Accurate detection and characterization of residual PEI in cell and gene therapy products
2. Effective detection and characterization of residual host cell proteins (HCP) in mAbs
3. Available technology and assays for quantifying process impurities
4. Current regulatory requirements for detecting, quantifying, and removing process impurities during biotherapy manufacturing
Keeping the (Adventitious) Virus Out of the (Adeno-Associated) VirusMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/2VRylbi
How can you keep an adventitious virus from contaminating your gene therapy that is delivered by an adeno virus vector? As viral vector bioprocessing advances, regulatory requirements for viral safety will as well. Learn how to define your viral clearance strategy for AAV delivered gene therapies.
How do you define a strategy for viral clearance for a process that inherently aims at purifying a virus?
Gene delivery using AAV has received a boost from two major approvals and the nearly 300 programs in the clinic. Novel gene therapies using viral vectors enable companies to transform the lives of people living with certain rare and ultra-rare diseases where treatments are often not available currently. Amongst a multitude of challenges in viral vector bioprocessing, uncertainty in regulatory expectations is a major challenge to gene therapy developers. Regulatory requirements are evolving as the science and manufacturing matures with more stringent measures for viral safety assurance expected for future approvals.
Learn how to implement techniques for adventitious virus removal in your viral vector process; we will focus on strategies for viral clearance along your journey towards commercial readiness of AAV-based processes.
In this webinar, you will learn:
• AAV process flows and focus areas for viral safety
• Strategies for implementing viral clearance measures in bioprocessing
• Case studies and data driven approaches on log reduction values (LRV) in a viral vector process
• Best practices and evaluation roadmaps on conducting viral clearance studies
Presented by: Ratish Krishnan, Senior Strategy Consultant, Novel Modalities Bioprocessing
Upcoming USP 665 - Level of Characterization of Single-Use Systems Today and ...MilliporeSigma
Register for the interactive, on-demand webinar now: https://bit.ly/USP665
Single-use plastic systems are being utilized more frequently especially for COVID-19 vaccine manufacturing. However, there are issues regarding standardization of quality information that limits implementation efficiencies. One of the challenges is the evaluation of leachables derived from a variety of different plastic components in a timely manner.
Since the USP <665> highlights a risk assessment approach with no typical pass/fail limit, approaches to decision-making based on the extractables data package will be reviewed. In addition, we will highlight legacy testing requirements which may not be necessary once USP <665> is implemented.
In this webinar, we will discuss:
- Regulatory expectations of extractables and leachables assessment today and tomorrow
- The right criteria that need to be assessed to select the type and quality of plastic materials for use in biopharmaceutical manufacturing
Upstream Viral Safety: A Holistic Approach to Mitigating Contamination RisksMilliporeSigma
The document discusses strategies for mitigating viral contamination risks in upstream biomanufacturing processes. It outlines a holistic approach involving careful selection and testing of raw materials, risk analysis to identify high-risk components, and various mitigation technologies like gamma irradiation, HTST pasteurization, and virus retentive filtration. Virus retentive filters designed specifically for cell culture media can provide over 4 logs of viral reduction while maintaining media performance. Combined with other controls, these strategies aim to prevent viral contamination upstream and reduce risks of disruption to operations.
Accelerating COVID-19 Therapies: How a streamlined biosafety strategy can get...Merck Life Sciences
Access the interactive recording: https://bit.ly/2xB2eRs
Abstract:
Vaccine and other biologic developers have long relied on traditional, growth-based methods for the detection of adventitious agents in a biosafety testing package. However, at a time where speed is of the essence, relying on testing methods that take many weeks is a real concern. Fortunately, alternative rapid detection methods can shorten timelines significantly — especially for Phase I testing. Here we will take you through these rapid alternatives and outline a testing strategy that can bring your therapy to the clinic faster.
Process Development for Cell Therapy and Viral Gene TherapyMerck Life Sciences
Today’s viral vector manufacturing processes remain challenging. Process development is a critical enabler to bring safe, effective, sustainable products to market to address patient needs. When done properly, it can reduce the timeline of the project and the cost of producing the therapeutic product.
The webinar discusses our strategies for developing lentivirus and adeno associated virus (AAV) and the impact these early decisions can have on commercial readiness.
Watch the interactive webinar now: https://bit.ly/2VplwQq
Biopharma Production and Development China 2015 Rita Barry
As the BioPharma industry grows in China and the Asian region, we invite you to be a part of this tremendous growth & development opportunities!
IBC’s Biopharma Development & Production Week in China is THE meeting place for biopharma industry professionals and scientists to get the highest quality and practical information that will enable them to develop competitive advantages and advance their capabilities in developing and manufacturing cell lines, biosimilars, biobetters, vaccines or novel biologics.
Top Reasons Why You Should Participate:
- Establish Business Partnerships with Chinese/Asian drug developers and contract
manufacturers
- Learn technical & practical know how from experiences on the ground in Asia
- Showcase your cutting edge solutions in front of key China/Asian Biopharma
decision makers
http://www.biopharmaproduction.com
In this webinar, you will learn:
Sources of endotoxin contamination
Contamination control strategy
Endotoxin removal strategies
Detailed description:
Endotoxin, a lipopolysaccharide (LPS), is a type of pyrogen and is a component of the exterior cell wall of Gram-negative bacteria. To ensure safety on patient’s endotoxin content in the drug should always be controlled. In a biological processing it may emanate from facility, utility, raw materials, process, and personnel. In this webinar we discuss the regulatory norms, strategies for prevention & removal of endotoxin to ensure that the final drug product is safe.
Aseptic Process Sampling to address Risk of Contamination & Containment in co...MilliporeSigma
Watch this webinar here: bit.ly/asepticwebinar2020
In this webinar, you will learn:
- The challenges tied to contamination control within a biopharmaceutical environment.
- What closed processing is, and how sampling solutions are an integral component towards that end.
- Advantages of sterile sampling from both a technical and economical viewpoint; with the review of a technical study confirming contamination risk reduction and total cost of ownership.
- Recommendations and requirements stated by these major regulatory authorities around the monitoring of the manufacturing process with the execution of sampling.
Detailed description:
Biopharmaceutical manufacturers are required to ensure drug product quality attributes for patient safety. Strong contamination control strategies should be considered early in process design, and have direct influence on the production environment and equipment selection.
Sampling at each step is a critical component in maintaining a contamination control strategy. Regulators are critical in the sampling process, as it predicts the state of the product or process, and needs to be Representative. A case study will be presented that demonstrates a closed, robust sampling solution capable of maintaining a sterile flow path when challenged with Brevundimonas diminuta. The sampling option you select can help support your goal in achieving a closed process, improving your risk mitigation strategy and product safety.
Excipients selection for high risk formulations Smita RajputMerck Life Sciences
Are you choosing the right excipients for your high risk application? Find out how to select the right excipients and enable your process optimization to improve the total cost of ownership.
In this webinar, you will learn:
• Selection of right excipients for high risk formulation is very critical step
• Low Endotoxin and low bioburden limits are important aspect while selecting raw materials
• Strong regulatory support is crucial for high risk formulation
Excipients selection for high risk formulations like parenteral and ophthalmic applications is very challenging. Excipients should be inert with high purity for such dosage forms because trace amounts of impurities present in excipients can interact with active pharmaceutical ingredient (API) which results in instability of the formulation. This presentation discusses how to select the right excipients for high-risk applications and gives guidance for process optimization by choosing the best combination of filters and excipients to improve the total cost of ownership.
Employing Innovative Platform Manufacturing and Biosafety Testing for your Ge...MilliporeSigma
Watch the webinar here: https://event.on24.com/wcc/r/2003970/F5AFA4FE6C60AD00635D4D15BADB5D8E?partnerref=slideshare
As gene therapies and gene-modified cell therapies show increasing promise, the need for innovative and proficient viral vector manufacturing continues to grow. Concurrently, increased regulatory guidance governing the manufacturing and testing of viral vectors adds complexity and increases the timelines to successfully produce high-quality virus ready for clinical use.
This webinar will address how the implementation of both manufacturing templates and platform characterization and safety assays can increase the likelihood of success in process validation and reduce risk in the timeline to commercialization for your gene therapy product. Using adeno-associated virus (AAV) as a case study, we will demonstrate how our validated, templated process for production can reduce the need for qualification inherent in niche manufacturing workflows and anticipate forthcoming needs for process performance qualification. This webinar will also highlight benefits from a new, platform assay offering for characterization and safety testing of AAV. Because these assays are pre-qualified, they reduce the variability inherent in assay validation and subsequently the time needed to establish readiness for regulatory compliance.
While these developments increase the standardization across the manufacturing and testing workflows, they remain flexible to clients' needs and are created to be scalable and as future-proof as possible, allowing for adaptability as the regulatory landscape of gene therapies evolves.
In this webinar, you will learn:
● The unit operations in AAV manufacturing that are ideal for templating
● How the manufacturing workflow can be targeted to reduce variability in testing and improve readiness for commercial production
● How platform assays can ease the burden of assay qualification and improve overall commercialization timelines
Rapid Methodologies for Biosafety Testing of Biologic TherapeuticsMerck Life Sciences
Learn about existing and emerging methods to accelerate biosafety testing of biologic therapies.
Speed to market for biologic therapeutics is ever more critical. However, the critical safety tests for these molecules, for example screening for adventitious agents such as viral contaminants, can be time consuming as well as challenging and laborious. Join us for this webinar as we explore how rapid methodologies are being used to not only accelerate this process, but also enhance quality by reducing testing complexity. Existing technologies as well as emerging trends will be discussed, along with the implications these may have on the regulatory landscape.
In this webinar you will learn:
● Which existing and emerging technologies are having now, and will have in the future, an impact on biosaftey testing.
● The benefits as well as risks of employing rapid methods for biosafety screening.
● How the regulatory agencies are reacting to rapid testing methods as alternatives to existing methods.
This document summarizes PCT's vision and history as a leader in cell therapy manufacturing. PCT aims to make transformative cell-based therapies accessible to all through providing high-quality and scalable manufacturing services. Over 30 years, PCT has gained unprecedented expertise manufacturing over 20 cell therapy products and treating over 6,000 patients. PCT partners with companies from start-ups to large pharmaceutical companies, and aims to guide clients through the entire development and manufacturing process.
This document provides information about the Cell & Gene Therapy conference taking place on October 10-11, 2018 in London. It includes details about the agenda, speakers, workshops, and registration information. The two-day conference will focus on topics related to manufacturing, regulation, and translational research of cell and gene therapies. There will be presentations from industry experts on developing stem cell and gene therapies, as well as workshops on practical development issues and competitive intelligence in the cell and gene therapy field.
One of the hottest topics in the biopharmaceutical industry today is “continuous bioprocessing”. Buzzwords such as “process intensification”, “next generation bioprocessing”, “process optimization”, and “integrated, connected manufacturing” are prevalent in industry conference programs and biopharma trade publications. This is no surprise considering that by 2025, it is expected that 20 percent of revenue from molecules that are still in the pipeline today will come from drugs manufactured with next generation technologies. It is estimated that roughly 35 percent of today’s commercial molecules will utilize process intensification methods within the next 5-10 years.
But what actually is next generation bioprocessing? How are industry players defining next generation bioprocessing and how will they pursue and successfully implement this approach? And is continuous bioprocessing always the ultimate end goal drug manufacturers around the globe are, or should be, striving for?
In this dedicated supplement, experts from both biologics manufacturers and from Merck provide their insights and perspectives on the on-going paradigm shift towards next generation bioprocessing occurring in today’s and tomorrow’s biopharma landscape.
“The Most Recommended Pharma & Life Sciences Solution providers in 2021” highlighting the pharmaceutical and healthcare industries help to improving the human health and forwarding life-expectancy one step further.
The Future of Bioprocessing – What you need to know.MilliporeSigma
One of the hottest topics in the biopharmaceutical industry today is “continuous bioprocessing”. Buzzwords such as “process intensification”, “next generation bioprocessing”, “process optimization”, and “integrated, connected manufacturing” are prevalent in industry conference programs and biopharma trade publications. This is no surprise considering that by 2025, it is expected that 20 percent of revenue from molecules that are still in the pipeline today will come from drugs manufactured with next generation technologies. It is estimated that roughly 35 percent of today’s commercial molecules will utilize process intensification methods within the next 5-10 years.
But what actually is next generation bioprocessing? How are industry players defining next generation bioprocessing and how will they pursue and successfully implement this approach? And is continuous bioprocessing always the ultimate end goal drug manufacturers around the globe are, or should be, striving for?
In this dedicated supplement, experts from both biologics manufacturers and from MilliporeSigma provide their insights and perspectives on the on-going paradigm shift towards next generation bioprocessing occurring in today’s and tomorrow’s biopharma landscape.
The key technological advances in assay development in recent years have been the use of magnetic microspheres and polymer beads as the solid phase in automated immunoassays. This has enabled automation, faster reactions, increased sensitivity, and shorter assay times. Magnetic beads and polymer beads allow assays to work in three dimensions, dramatically increasing surface area and sensitivity compared to traditional ELISAs or coated tubes. IVD manufacturers must consider factors like accuracy, reproducibility, stability, and ease of adaptation when developing assays for instrument systems. Forming collaborations with academic researchers is important for assay development to help discover new biomarkers and opportunities to add new tests.
The document discusses challenges and opportunities in the development of biosimilars. It provides perspectives from several industry experts on the top hurdle being a lack of clarity around intellectual property and marketing strategies as well as high development costs. The experts note that developing the necessary skill sets around quality by design, analytics, and clinical trial design is key to overcoming hurdles in developing biosimilars safely and effectively.
Shamisha Learning Center, Ahmedabad, Gujarat, India-Specialized Training, Workshops and courses on Quality, Regulatory, R & D, Supply Chain and Manufacturing
The 10 Most Innovative Pharma and Biotech Solution Providers, 2020 September ...Merry D'souza
The 10 most innovative pharma and biotech solution providers, 2020 september 2020; Insights Success has published The 10 most innovative pharma and biotech solution providers.
This document discusses opportunities and challenges for integrated contract research and manufacturing services (CRAMS) companies in India. As drugs worth $85 billion go off patent by 2020, it represents an opportunity for Indian generic drug companies and CRAMS industry. CRAMS companies can partner with innovator companies in drug development from conceptualization to commercialization. However, low drug success rates and stringent regulatory requirements pose challenges. The document analyzes strengths like qualified scientists, weaknesses like quality issues, opportunities like market growth, and threats like increasing regulatory standards facing integrated CRAMS companies in India.
Artificial intelligence robotics and computational fluid dynamics Chandrakant Kharude
The document discusses applications of artificial intelligence, robotics, and computational fluid dynamics in the pharmaceutical industry. It provides introductions and definitions for each technology, as well as their current and potential applications. Some key applications discussed include using AI for disease identification, personalized treatment, drug discovery/manufacturing, and clinical trials. Applications of robotics mentioned include use in research and development, packaging, sterile syringe filling, and laboratory automation. Current challenges and future directions are also addressed.
ICWES15 - Medical Devices - Partnering for Success. Presented by Prof Karen R...Engineers Australia
The document discusses the Medical Device Partnering Program (MDPP) which aims to improve collaboration between medical device companies and research organizations in Australia. The MDPP provides a single point of contact for small companies to access expertise and helps establish partnerships to work on early-stage projects. It has successfully brought researchers and companies together on over 100 projects, resulting in new medical device prototypes and establishing new relationships between organizations. The MDPP helps address barriers between industry and research to facilitate more applied outcomes.
The CRO industry is valued at $25-30 billion globally and is growing at a rate of 7-9% annually. Preclinical services make up 25% of spending while phases I-IV clinical trials account for 75%. Growth has been driven by increasing trial volumes, complexity, and the ability of CROs to perform services more cost efficiently. Top CROs now account for 50% of the market. Emerging trends include personalized medicine approaches and use of big data, virtual trials, and digital biomarkers. To remain competitive, large CROs need to innovate in these areas and develop new models to better serve smaller biotechs and pharmaceutical companies.
Pfizer, GE Healthcare, Novartis Pharma and Boehringer-Ingelheim Pharma Confir...Torben Haagh
Want to learn more about how to cover gaps for IDMP implementation until July 1st 2016? Then join experts at the International Conference IDMP Implementation - Impact on Data, Systems and Processes taking place in Berlin from 24 – 25 June 2015.
There are limited places available, so make sure you secure your conference ticket today! Learn more here.
Don't miss this unique opportunity to hear expert presentations, take part in interactive workshops and meet with IDMP experts from around the world including participation from:
• Pfizer Inc. • Boehringer-Ingelheim Pharma GmbH & Co. KG • F. Hoffmann-La Roche Ltd. • Marr Consultancy Ltd • GE Healthcare • A.E.Tiefenbacher GmbH & Co. KG • Bundesinstitut für Arzneimittel und Medizinprodukte • Bundesverband der Arzneimittel-Hersteller e.V. • MEDA Pharma GmbH & Co. KG • Mylan EPD, Inc. • Janssen Pharmaceuticals, Inc. • Novartis Pharma AG and many more.
Want to know more regarding this topic area? Then join us at our
IDMP Implementation - Impact on Data, Systems and Processes
24 – 25 June 2015 | Steigenberger Hotel Berlin, Germany
For more information take a look at our agenda here: http://bit.ly/IDMP_agenda
Or visit our website: http://bit.ly/IDMP_website
The document discusses establishing the OR Centre for Quality Sciences to provide consulting services to the pharmaceutical and biologics industries regarding quality, regulatory affairs, innovation, and technology. It aims to engage subject matter experts to support academia, industry, and government. The Centre will focus on shifting from a compliance to a quality culture and aligning with new regulatory expectations in a changing technological landscape with advances in areas like artificial intelligence and data sciences. It will provide training, reviews, audits, and other services to support quality systems, documentation practices, regulatory submissions, clinical trials, and more.
The document discusses future prospects and challenges for biotherapeutics. It begins by defining biotherapeutics as products produced using living cells or organisms, such as recombinant hormones, vaccines, monoclonal antibodies, growth factors, and gene and cell therapies. It then contrasts biotherapeutics, biosimilars, and generics. The document outlines the complex manufacturing process for biotherapeutics and challenges in characterizing their large, complex structures. It concludes by discussing switching and interchangeability studies required to demonstrate a biosimilar is as safe and effective as the reference biologic.
The document discusses the development of mRNA therapeutics and the manufacturing challenges associated with them. Some key points:
- mRNA vaccines have advantages over traditional vaccines like speed of development and flexibility, but manufacturing challenges remain.
- Challenges include the supply of plasmid DNA, in vitro transcription processes, purification difficulties due to mRNA size/properties, and lipid nanoparticle formulation/delivery.
- Overcoming these challenges will help realize the potential of mRNA technology for a wide range of applications from mass vaccines to personalized cancer immunotherapies, which may require flexible small-batch manufacturing capabilities. Addressing production bottlenecks and developing standardized tools/processes can accelerate development.
SMi Group's AI in Drug Discovery 2020 conferenceDale Butler
This document provides information about an upcoming conference on AI in Drug Discovery taking place from March 16-17, 2020 in London, UK. It includes details about the program, speakers, registration fees and deadlines. The conference will explore how machine learning and AI are being applied across the drug discovery process, from compound design and virtual screening to toxicity prediction. There will be case studies presented from major pharmaceutical companies on their experience integrating AI. The document also advertises sponsorship opportunities for the event.
Farm is an ISO 13485-certified and FDA-compliant product development consultancy with over 40 years of experience helping medical, life sciences, and consumer healthcare companies. It offers expertise in areas like user research, engineering, design, and regulatory compliance. Farm helps clients design devices that are safe, easy to use and effective by employing research, usability testing, and a process-driven development approach.
Similar to Article: On the Cusp of Curing Disease (20)
The Viscosity Reduction Platform: Viscosity-reducing excipients for improveme...MilliporeSigma
Protein viscosity is a major challenge in preparing highly concentrated protein formulations suitable for subcutaneous injection. Recently, the Viscosity Reduction Platform (VRP) was introduced and its technical key features and benefits for formulations were discussed. However, highly viscous solutions do not only pose a challenge when administering a drug to a patient, they can also impose technical limitations in the manufacturing process.
This white paper evaluates the effect of the excipients in the Viscosity Reduction Platform on ultrafiltration processes used to produce a highly concentrated formulation of a monoclonal antibody (mAb). Two filtration methods are demonstrated in this work.
Find more information about the Viscosity Reduction Platform on our website: https://www.sigmaaldrich.com/products/pharma-and-biopharma-manufacturing/formulation/viscosity-reduction-platform
Use of Excipients in Downstream Processing to Improve Protein PurificationMilliporeSigma
Excipients are used to improve the stability of protein-based therapeutics by protecting the protein against a range of stress conditions such as temperature changes, pH changes, or agitation. Similar stresses are applied to proteins during downstream purification. Shifts in pH during Protein A chromatography, subsequent incubations at low pH for virus inactivation, and changes in conductivity in ion exchange chromatography can lead to aggregation, fragmentation, or other chemical modifications of the therapeutic protein. Given the potential impact on the protein’s structural integrity, there is a need for approaches to reduce the risk presented by the conditions during downstream processing. For example, integration of a solution to prevent aggregation of proteins would be a more efficient strategy than implementing steps to remove multimeric forms.
This white paper highlights the results from a recent paper by Stange et. al., in which protein stabilizing excipients such as polyols, sugars, and polyethylene glycol (PEG4000) were used as buffer system additives. Effect of the excipients on elution patterns, stabilization of the monomer antibody, host-cell protein removal, virus inactivation rates and binding capacity of cation exchange chromatography were explored.
Exploring the protein stabilizing capability of surfactants against agitation...MilliporeSigma
Agitation of therapeutic protein solutions during manufacturing, shipping and handling is one of the major initiators for protein aggregation and particle formation during the life history of a protein drug. Adsorption of protein molecules to liquid-air interfaces leads to the formation of highly concentrated protein surface films. The rupture of these protein films due to various mechanical processes can then result in the appearance of protein aggregates and particles in the bulk solution phase.
One technique to stabilize proteins against stress induced by liquid-air interfaces is the use of non-ionic surfactants. About 91% of antibody formulations commercially available in 2021 contained a surfactant. Polysorbate 20 and 80, composed of a hydrophilic polyoxyethylene sorbitan and hydrophobic fatty acid esters, made up the largest part being employed in 87% of said formulations.
Despite their frequent use in parenteral drug products, concerns have been raised for decades about the application of polysorbates as surfactants in biopharmaceutical formulations. Autoxidation of polysorbate, caused by residual peroxides in polysorbates, can damage the proteins and can further drive the oxidative degradation of polysorbate. Chemical and enzymatic hydrolysis of polysorbate may lead to the formation of free fatty acid particles, which may become visible; and both mechanisms eventually lead to the reduction in polysorbate concentration. Therefore, the purpose of the current study was to compare various molecules for their capabilities to reduced agitation-induced protein aggregation and particle formation; and furthermore, investigate their underlying protein stabilizing mechanisms.
The Viscosity Reduction Platform: Viscosity Reducing Excipients for Protein F...MilliporeSigma
Protein viscosity is one of the major obstacles in preparing highly concentrated protein formulations suitable for subcutaneous injection.
This whitepaper examines how combining an amino acid with a second viscosity-reducing excipient circumvents adverse effects on protein stability and improves viscosity-reducing capacity.
To find more information about the Viscosity Reduction Platform, please visit our website: https://sigmaaldrich.com/products/pharma-and-biopharma-manufacturing/formulation/viscosity-reduction-platform
Characterization of monoclonal antibodies and Antibody drug conjugates by Sur...MilliporeSigma
The document discusses characterization of antibodies and antibody-drug conjugates (ADCs) using surface plasmon resonance (SPR). It provides details on:
1. Using SPR to characterize binding kinetics of ADCs and determine effects of different linker types and drug-antibody ratios on antigen binding. SPR shows reduced but detectable binding for ADCs versus the unconjugated antibody.
2. An application of SPR to study binding interactions of SARS-CoV-2 spike protein and mutants with the ACE2 receptor and anti-spike antibodies. This can aid understanding of viral mutations and inform vaccine and drug development.
3. SPR is proposed as a method to screen binding kinetics of spike protein mutants to evaluate effects
The Role of BioPhorum Extractables Data in the Effective Adoption of Single-U...MilliporeSigma
Regulatory expectation does require patient safety evaluations with supporting data for manufacturing components that directly come into contact with drug manufacturing process streams. Readily available extractables data can help manufacturers using singleuse technology to accelerate product qualifications, risk assessments and process optimization
This white paper guides you on how to save time and resources with supplier-provided single-use system extractables data and gives you an overview about the overall strategy for Extractables & Leachables. At the end you will find a case study.
Find more information about filters and single-use components on our website: https://www.sigmaaldrich.com/DE/en/services/product-services/emprove-program/emprove-filter-and-single-use-component-portfolio
The Future of Pharma- and Biopharmaceutical AuditsMilliporeSigma
The document discusses how COVID-19 has changed pharma and biopharmaceutical audits, with remote audits now accepted by regulatory authorities. It explores the benefits of different audit approaches like remote, virtual, and hybrid audits and the features that enable each. Regulatory bodies are adopting new guidance for remote inspections and assessments. Looking ahead, risk-based planning and digital solutions will allow the industry to conduct more flexible and agile audits, though on-site audits will still be necessary at times. Hybrid audits combining various approaches are positioned as the future of auditing.
Moving your Gene Therapy from R&D to IND: How to navigate the Regulatory Land...MilliporeSigma
Watch the recording of this presentation here: https://bit.ly/3SqOsoP
Novel therapies, including cell and gene therapies, continue to be central to innovation in healthcare and represent the fastest growing area of therapeutic medicine. As a consequence, the number of gene therapies undergoing clinical trials has increased significantly in the last five years.
Manufacturing processes for these novel therapeutics are very complex with a high risk of contamination. Regulatory agencies world-wide have responded by issuing guidance to outline their expectations for development and manufacture of cell and gene therapies. Currently, regulatory guidance is not harmonized globally and can often lead to confusion within industry and increased risk of non-compliance.
In this webinar, we'll answer:
• Which regulatory guidelines do you need to comply for your INDs?
• When do you start implementing GMPs and validated assays?
• How do you get your QC testing strategy ‘right the first time’?
• How do you ensure testing is not your rate limiting step for the IND submission?
Presented by:
Manjula Aysola, Senior Regulatory Consultant
Dr. Alison Armstrong, Sr. Director, Technical and Scientific Solutions
Identity testing by NGS as a means of risk mitigation for viral gene therapiesMilliporeSigma
Watch the presentation of this webinar here: https://bit.ly/3RijkHC
Detailed description:
Imagine you’ve just completed a manufacturing run for your viral vector. Identity testing is performed to confirm the vector sequence. But when the results come back the data reveals unexpected sequence variants! With an appropriate risk mitigation testing strategy, this situation can be prevented.
The situation described above is not hypothetical, and happens more that you think, costing valuable time and resources.
Investigatory testing has shown that sequence variants present in starting materials (e.g. plasmids) are likely to make their way to the final product. Adequate identification of low-level variants with an appropriately sensitive method is critical in ensuring the quality of the final product. A risk-based testing strategy, in the context of identity, for viral vector manufacturing will be presented, focusing on key testing points. NGS assays for identity and variant detection will be highlighted due to their extremely sensitive nature compared to traditional approaches.
In this webinar, we'll explore:
• Regulatory requirements for identity testing
• NGS applications for identity testing as compared to traditional methods
• A case study on the impact of not establishing a proper risk-based testing strategy
Presented by: Bradley Hasson, Director of Lab Operations for NGS Services
Latest advancements of melt based 3D printing technologies for oral drug deli...MilliporeSigma
Watch the presentation of this webinar here: https://bit.ly/3A2WcH4
The application of polymer excipients in 3D printing manufacturing is usually limited due to the concerns of filament strength, high processing temperature and large scale manufacturing.
Latest technology developments are targeting a direct melt deposition to simplify the process and enable a constant and efficient process. Two different processing approaches will be presented:
The advanced melt drop deposition, where individual three dimensional geometries can be created by depostition of polymer droplets and the MED® 3D printing technology which allows by precise layer-by-layer deposition to produce objects with well-designed geometric structures.
In this webinar, you will learn:
• Latest advancements of melt based 3D printing approaches
• Application examples for the individual technologies
• Deep dive in the MED® 3D printing technology to design dedicated drug release profiles
Presented by:
Dr. Thomas Kipping, Head of Drug Carriers
Dr. Xianghao Zuo, Deputy Director of R&D, Triastek
CAR-T Manufacturing Innovations that Work - Automating Low Volume Processes a...MilliporeSigma
Watch the presentation of this webinar here: https://bit.ly/3NDNIKe
Automated, fit-for-purpose tools are essential in CAR-T processing to support sustainable manufacturing of clinical and market-approved cell therapy products. This webinar will discuss how the ekko™ Acoustic Cell Processing System uses acoustic technology as a touchless approach to manipulate cells, enabling a modular tool across the CAR-T manufacturing workflow. Typical performance of templated ekko™ System processes for DMSO washout of leukapheresis material, low volume and high cell concentrate for electroporation preparation, and harvest of expanded T cells will be reviewed.
This webinar will also give an early glimpse at the ekko™ Select System for unmatched T cell selection.
In this webinar, you will:
• Uncover how the ekko™ System supports the broad industrialization of cell therapy, with particular focus on how to achieve low volume, high concentrate cell product for critical transduction and transfection steps
• Discover how ekko™ System for wash and concentrate processes throughout the cell therapy workflow achieve high cell recovery, viability, and effective residual removal
• Preview to ekko™ Select, our cell therapy selection platform, to achieve unmatched ease-of-use with direct processing from leukopaks reducing the need for preparation steps
Presented by:
Benjamin Ross-Johnsrud, Acoustic Technology Expert
Robert Scott, Mechanical Engineer III
How does the ICH Q5A revision impact viral safety strategies for biologics?MilliporeSigma
The document discusses the expected revision of ICH Q5A guidance on viral safety of biotechnology products. Key points include:
1) ICH Q5A is being revised to address new biologic modalities like viral vectors and advances in manufacturing and detection methods.
2) The revision will provide more flexibility in viral clearance validation strategies and acceptance of alternative detection methods like PCR and HTS.
3) Challenges for viral safety of advanced manufacturing will also be discussed, as the original guidance does not address emerging approaches.
Improve Operational Efficiency by Over 30% with Product, Process, & Systems A...MilliporeSigma
Watch the presentation of this webinar here: https://bit.ly/3adaxWh
When implementing new automation systems, organizations must consider things like deployment time, user adoption, and costs.
They must also consider the cost of doing nothing – that is, what competitive advantage is lost in standing still? What time and quality is lost in repetitive, manual tasks rather than an automated, digital workflow? What operational efficiencies are lost?
In this webinar we examine how a product, process, and system agnostic automation platform can be deployed faster than traditional system specific software while bringing greater operational efficiencies (in many cases over 30% improvement).
To remain competitive in the market, biopharma manufacturers must adopt automation and digital technologies, but most plants still have island of automation consisting of independently functioning, standalone unit operations. This results in operational inefficiency, regulatory concerns, and a poor understanding of the process and product life cycle.
Taking the first, right step must include considering risks, costs, timelines, and technology alternatives. Traditional automation approaches tied to specific systems, processes, and products are, by their nature, limited; while an agnostic platform will address current biomanufacturing business challenges and ensure future readiness. With the right platform, a phased automation implementation can yield operational efficiency gains of up to 30% and improved product quality and regulatory compliance.
In this webinar, let's explore:
• Challenges of automation and digital technology adoption
• What a product, process, and system agnostic platform entails
• Applications and benefits of a process orchestration platform
• Ensuring future readiness with process orchestration
Presented by:
Braj Nandan Thakur, Global Product Manager - Automation
Insights from a Global Collaboration Accelerating Vaccine Development with an...MilliporeSigma
Watch the presentation of this webinar here: https://bit.ly/3Nbb5ug
Get insights and best practices from a multinational team establishing a platform for vaccine production. See how a long-term collaboration on a bench-scale process used to produce a Virus Like Particle (VLP) vaccine for SARS-CoV-2 was successfully converted to a robust GMP-compatible, scalable process.
The COVID-19 pandemic further emphasized the need for collaboration in the development of urgently needed vaccines and therapeutics. In this webinar, we take you behind the scenes of our collaboration with Technovax and Innovative Biotech in which a scalable VLP vaccine platform was optimized for use in a production facility in Nigeria in response to the need for local production of SARS-CoV-2 vaccines. The flexibility and robustness of the platform will enable its rapid deployment to support the West African pandemic readiness program. Initial development of the VLP process began in late 2019 and by March 2020, was already adapted for production of a SARS-CoV-2 vaccine.
In this webinar, you will learn:
• About building a priceless collaborative network with integrated solutions
• Virus-Like Particle Vaccines
• Process Development Overview and Challenges
• Pre-clinical Results and Next Steps
Presented by:
Jose M. Galarza, PhD,
President and Founder of TechnoVax
Naomi Baer,
Business development consultant, Emerging Biotech, BioProcess division
Youssef Gaabouri, Eng. ,
Associate Director, Head of Sales Middle East & Africa, BioProcess division
Risk-Based Qualification of X-Ray Sterilization for Single-Use SystemsMilliporeSigma
Watch the presentation of this webinar here: https://bit.ly/3vQf0qv
In the single-use bioprocess industry, X-ray irradiation warrants consideration as an alternate sterilization technology. Using a risk-based qualification testing strategy is important when evaluating and implementing equivalent ionizing irradiation sterilization methods.
The urgent need for life-saving therapies as a result of the global pandemic has reinforced the criticality of flexibility in pharmaceutical manufacturing, including sterilization. The single-use bioprocess industry traditionally has employed gamma irradiation sterilization. X-ray irradiation is being considered as an additional sterilization technology for business and supply continuity. We will share a risk-based qualification testing strategy including Extractables and data generated to support comparability of gamma irradiation and X-ray irradiation as equivalent ionizing irradiation sterilization methods.
In this webinar, you will learn about:
• The comparison of gamma and X-ray irradiation sterilization
• A risk-based qualification test strategy
• Data evaluation of gamma versus X-ray sterilized single-use components
Presented by:
Monica Cardona,
Global Senior Program Manager
Paul Killian, Ph.D.,
R&D Director, Analytical Technologies
Rapid Replication Competent Adenovirus (rRCA) Detection: Accelerate your Lot ...MilliporeSigma
Watch the presentation of this webinar here: https://bit.ly/3MJ4u9V
Testing for presence of replication competent adenovirus (RCA) is a key component to ensure patient safety and a requirement for all biologicals manufactured using adenoviral vectors. For many adenoviral-based products, the RCA assay is a rate-limiting assay for lot release.
Join this webinar to learn about a rapid RCA detection assay currently in development, which combines a 7-day culture assay with a highly sensitive molecular endpoint specific for RCA. The method can detect presence of as little as 1 RCA in adenoviral vector material at an approximate concentration of 5x107 - 2x108 vector particles (VP)/mL, making it a suitable method to meet regulatory requirements while accelerating your lot release timelines.
In this webinar, you will learn about:
• Regulatory framework for adenoviral vector products
• Considerations for lot release testing of adenoviral-based therapies
• Advantages of a rapid method for RCA testing on production lot material
Presented by:
Axel Fun, Ph.D.,
Principal Scientist
Alberto Santana, MBA,
Product Manager, Biologics Biosafety Testing
The High Intensity Sweeteners Neotame and Sucralose: 2 Ways to ace the Patien...MilliporeSigma
Watch the presentation of this webinar here: https://bit.ly/3vQyN7K
Bitter medicines are an important issue, especially for pediatric applications. As several APIs have bitter tasting components, high intensity sweeteners for taste optimization are of great interest. Join our webinar to discover our new sweetener toolbox enabling safe and stable formulations.
Mask bitter aftertaste for a sweeter pill to swallow! Patients’ compliance and the therapeutic benefit are supported by a pleasant taste of pharmaceutical formulations. With the high intensity sweeteners Neotame and Sucralose, you have efficient tools at hand which are superior to other sweeteners in many aspects:
• excellent sugar-like taste profile
• outstanding sweetness factors
• use effectiveness
• enhanced stability
We will present our new toolbox of two high performance sweeteners and focus on aspects of stability, safety, the application in various dosage forms, and market perception.
In this webinar, you will learn:
• How to optimize the patients' taste experience of your pharmaceuticals
• How sweeteners can be differentiated by their sensory profiles and features
• How our new product offering Neotame can be effectively used in your targeted formulations
Presented by:
Almut von der Brelie,
Senior Manager Strategic Marketing, Excipients for Solid Applications
The Developability Classification System (DCS): Enabling an Optimized Approac...MilliporeSigma
This whitepaper by Dr. Daniel Joseph Price outlines how poorly soluble drug formulations can be designed using the developability classification system (DCS).
The DCS identifies the root cause of low solubility and enables lean, cost-effective and effective formulations to be developed.
#solubility #pharmaceuticalmanufacturing #oralsoliddosage #drugdevelopment
How to Accelerate and Enhance ADC TherapiesMilliporeSigma
In this webinar, you will learn about:
The advantages of using advanced intermediates to develop ADC therapies
How to increase ADC solubility and efficiency
Fast, small-scale ADC library generation
Seamless supply chain with reduced complexity and regulatory support
The ADCore product line offers versatile intermediates that simplify the synthesis of common ADC payloads (dolastatins, maytansinoids, and PBDs) by greatly reducing the number of synthetic steps. This translates to savings in development and manufacturing costs and shorter timelines to the clinic. To address the poor solubility of many ADC payloads, ChetoSensar™ was developed to significantly increase the hydrophilicity of the drug linker, which has been shown to also substantially increase the efficacy of ADCs and broaden the therapeutic window.
Lastly, the ADC Express™ service leverages conjugation chemistry and analytical expertise to help design and quickly synthesize sets of potential ADC therapies suitable for screening to simplify candidate selection and get ADC therapies to market faster.
The story of Dr. Ranjit Jagtap's daughters is more than a tale of inherited responsibility; it's a narrative of passion, innovation, and unwavering commitment to a cause greater than oneself. In Poulami and Aditi Jagtap, we see the beautiful continuum of a father's dream and the limitless potential of compassion-driven healthcare.
Hypertension and it's role of physiotherapy in it.Vishal kr Thakur
This particular slides consist of- what is hypertension,what are it's causes and it's effect on body, risk factors, symptoms,complications, diagnosis and role of physiotherapy in it.
This slide is very helpful for physiotherapy students and also for other medical and healthcare students.
Here is summary of hypertension -
Hypertension, also known as high blood pressure, is a serious medical condition that occurs when blood pressure in the body's arteries is consistently too high. Blood pressure is the force of blood pushing against the walls of blood vessels as the heart pumps it. Hypertension can increase the risk of heart disease, brain disease, kidney disease, and premature death.
nursing management of patient with Empyema pptblessyjannu21
prepared by Prof. BLESSY THOMAS, SPN
Empyema is a disease of respiratory system It is defines as the accumulation of thick, purulent fluid within the pleural space, often with fibrin development.
Empyema is also called pyothorax or purulent pleuritis.
It’s a condition in which pus gathers in the area between the lungs and the inner surface of the chest wall. This area is known as the pleural space.
Pus is a fluid that’s filled with immune cells, dead cells, and bacteria.
Pus in the pleural space can’t be coughed out. Instead, it needs to be drained by a needle or surgery.
Empyema usually develops after pneumonia, which is an infection of the lung tissue. it is mainly caused due in infectious micro-organisms. It can be treated with medications and other measures.
CHAPTER 1 SEMESTER V COMMUNICATION TECHNIQUES FOR CHILDREN.pdfSachin Sharma
Here are some key objectives of communication with children:
Build Trust and Security:
Establish a safe and supportive environment where children feel comfortable expressing themselves.
Encourage Expression:
Enable children to articulate their thoughts, feelings, and experiences.
Promote Emotional Understanding:
Help children identify and understand their own emotions and the emotions of others.
Enhance Listening Skills:
Develop children’s ability to listen attentively and respond appropriately.
Foster Positive Relationships:
Strengthen the bond between children and caregivers, peers, and other adults.
Support Learning and Development:
Aid cognitive and language development through engaging and meaningful conversations.
Teach Social Skills:
Encourage polite, respectful, and empathetic interactions with others.
Resolve Conflicts:
Provide tools and guidance for children to handle disagreements constructively.
Encourage Independence:
Support children in making decisions and solving problems on their own.
Provide Reassurance and Comfort:
Offer comfort and understanding during times of distress or uncertainty.
Reinforce Positive Behavior:
Acknowledge and encourage positive actions and behaviors.
Guide and Educate:
Offer clear instructions and explanations to help children understand expectations and learn new concepts.
By focusing on these objectives, communication with children can be both effective and nurturing, supporting their overall growth and well-being.
The Ultimate Guide in Setting Up Market Research System in Health-TechGokul Rangarajan
How to effectively start market research in the health tech industry by defining objectives, crafting problem statements, selecting methods, identifying data collection sources, and setting clear timelines. This guide covers all the preliminary steps needed to lay a strong foundation for your research.
"Market Research it too text-booky, I am in the market for a decade, I am living research book" this is what the founder I met on the event claimed, few of my colleagues rolled their eyes. Its true that one cannot over look the real life experience, but one cannot out beat structured gold mine of market research.
Many 0 to 1 startup founders often overlook market research, but this critical step can make or break a venture, especially in health tech.
But Why do they skip it?
Limited resources—time, money, and manpower—are common culprits.
"In fact, a survey by CB Insights found that 42% of startups fail due to no market need, which is like building a spaceship to Mars only to realise you forgot the fuel."
Sudharsan Srinivasan
Operational Partner Pitchworks VC Studio
Overconfidence in their product’s success leads founders to assume it will naturally find its market, especially in health tech where patient needs, entire system issues and regulatory requirements are as complex as trying to perform brain surgery with a butter knife. Additionally, the pressure to launch quickly and the belief in their own intuition further contribute to this oversight. Yet, thorough market research in health tech could be the key to transforming a startup's vision into a life-saving reality, instead of a medical mishap waiting to happen.
Example of Market Research working
Innovaccer, founded by Abhinav Shashank in 2014, focuses on improving healthcare delivery through data-driven insights and interoperability solutions. Before launching their platform, Innovaccer conducted extensive market research to understand the challenges faced by healthcare organizations and the potential for innovation in healthcare IT.
Identifying Pain Points: Innovaccer surveyed healthcare providers to understand their difficulties with data integration, care coordination, and patient engagement. They found widespread frustration with siloed systems and inefficient workflows.
Competitive Analysis: Analyzed competitors offering similar solutions in healthcare analytics and interoperability. Identified gaps in comprehensive data aggregation, real-time analytics, and actionable insights.
Regulatory Compliance: Ensured their platform complied with HIPAA and other healthcare data privacy regulations. This compliance was crucial to gaining trust from healthcare providers wary of data security issues.
Customer Validation: Conducted pilot programs with several healthcare organizations to validate the platform's effectiveness in improving care outcomes and operational efficiency. Gathered feedback to refine features and user interface.
Joker Wigs has been a one-stop-shop for hair products for over 26 years. We provide high-quality hair wigs, hair extensions, hair toppers, hair patch, and more for both men and women.
NURSING MANAGEMENT OF PATIENT WITH EMPHYSEMA .PPTblessyjannu21
Prepared by Prof. BLESSY THOMAS, VICE PRINCIPAL, FNCON, SPN.
Emphysema is a disease condition of respiratory system.
Emphysema is an abnormal permanent enlargement of the air spaces distal to terminal bronchioles, accompanied by destruction of their walls and without obvious fibrosis.
Emphysema of lung is defined as hyper inflation of the lung ais spaces due to obstruction of non respiratory bronchioles as due to loss of elasticity of alveoli.
It is a type of chronic obstructive
pulmonary disease.
It is a progressive disease of lungs.
Test bank clinical nursing skills a concept based approach 4e pearson educati...rightmanforbloodline
Test bank clinical nursing skills a concept based approach 4e pearson education
Test bank clinical nursing skills a concept based approach 4e pearson education
Test bank clinical nursing skills a concept based approach 4e pearson education
Solution manual for managerial accounting 18th edition by ray garrison eric n...rightmanforbloodline
Solution manual for managerial accounting 18th edition by ray garrison eric noreen and peter brewer_compressed
Solution manual for managerial accounting 18th edition by ray garrison eric noreen and peter brewer_compressed
India Medical Devices Market: Size, Share, and In-Depth Competitive Analysis ...Kumar Satyam
According to TechSci Research report, “India Medical Devices Market Industry Size, Share, Trends, Competition, Opportunity and Forecast, 2019-2029,” the India Medical Devices Market was valued at USD 15.35 billion in 2023 and is anticipated to witness impressive growth in the forecast period, with a Compound Annual Growth Rate (CAGR) of 5.35% through 2029. This growth is driven by various factors, including strategic collaborations and partnerships among leading companies, a growing population, and the increasing demand for advanced healthcare solutions.
Recent Trends
Strategic Collaborations and Partnerships
One of the most significant trends driving the India Medical Devices Market is the increasing number of collaborations and partnerships among leading companies. These alliances aim to merge the expertise of individual companies to strengthen their market position and enhance their product offerings. For instance, partnerships between local manufacturers and international companies bring advanced technologies and manufacturing techniques to the Indian market, fostering innovation and improving product quality.
Browse over XX market data Figures and spread through XX Pages and an in-depth TOC on " India Medical Devices Market.” - https://www.techsciresearch.com/report/india-medical-devices-market/8161.html
Enhancing Hip and Knee Arthroplasty Precision with Preoperative CT and MRI Im...Pristyn Care Reviews
Precision becomes a byword, most especially in such procedures as hip and knee arthroplasty. The success of these surgeries is not just dependent on the skill and experience of the surgeons but is extremely dependent on preoperative planning. Recognizing this important need, Pristyn Care commits itself to the integration of advanced imaging technologies like CT (Computed Tomography) and MRI (Magnetic Resonance Imaging) into the surgical planning process.
2024 Media Preferences of Older Adults: Consumer Survey and Marketing Implica...Media Logic
When it comes to creating marketing strategies that target older adults, it is crucial to have insight into their media habits and preferences. Understanding how older adults consume and use media is key to creating acquisition and retention strategies. We recently conducted our seventh annual survey to gain insight into the media preferences of older adults in 2024. Here are the survey responses and marketing implications that stood out to us.
3. User Guide Activity Budget Tracking App Steps to apply.pptx
Article: On the Cusp of Curing Disease
1. www.themedicinemaker.com
On the Cusp of
Curing Disease
Welcome to the M Lab™
Collaboration Centers – where
customers can use non-GMP lab
spaces to operate equipment, evaluate
processes and receive real-time
technical support without disrupting
production.
A Sponsored Supplement From
2. What is your role at the M Lab™
Collaboration Centers?
Elizabeth Goodrich: I lead the Application
Engineering team worldwide, and most
of our projects are run in the M Lab™
Collaboration Centers. We don’t work in
product development, but we do work
with products that are already launched
to develop best practices and other useful
informationthatwecandelivertocustomers
to help them streamline their own process
development efforts. Often, customers
come into the M Lab™ Collaboration
Centers so that we can address their
specific concerns – they can also learn more
about our products and test out different
processing strategies. These labs are situated
in nine different locations worldwide, so we
can reach customers wherever they are.
Ranjeet Patil: I lead the vaccine and viral
therapiesgroup,whichworkswithcustomers
in a consulting capacity. Many customers
cometotheMLab™CollaborationCenters
to look at our systems and hardware to get
a feel for what would be a good fit for them.
Gene therapy products are attracting a
great deal of attention so my group talks to
customers in this area.
What are the biggest needs of gene
therapy manufacturers?
RP:Thereisnowrapidgrowthinthepipeline
andthistranslatestoaneedforspeed.Speed
tomarketisnothingnew,butitresonateswith
gene therapy customers for a few different
reasons.Firstly,manycompaniesaretargeting
rare diseases – and, in many cases, patients
won’t have long to live without treatment.
Secondly, many of these drug programs
qualify for expedited approvals and other
companies may be chasing the same targets.
You may not have a viable business because
thereisn’talargepopulationtogoafterifyour
competitor is first to market.
Given that companies want to get to
market fast, many decide not to invest in
a physical footprint and instead look for a
CMO, but capacity at such companies is
extremely limited given how many people
are developing gene therapies. On the
other hand, even if a company wanted to
expand and have their own manufacturing
capacity, it is extremely challenging to build
and effectively operate spaces suitable for
gene therapy manufacturing. Infrastructure
for any kind of viral process is significantly
more expensive than for other classes of
biopharmaceuticals. Although there is clarity
on the clinical aspects of the process, the
manufacturing aspects are challenging
because there is no template approach –
every process is different and regulatory
guidance isn’t straight forward.
What do the M Lab™ Collaboration
Centers offer to customers?
EG: Many of the companies working on
gene therapies are small – perhaps even
virtual – so they have limited human and
laboratory resources at their disposal.
The M Lab™ Collaboration Centers
can be an extension of their resources,
giving them relevant tools to work with
and a place where they can test new
processing options.
We also have a full suite of single-
use products available in the centers for
customers to evaluate. Single use is a great
option for gene therapy manufacturers
because there is a huge need for
sterility and eliminating the potential
for cross contamination. Again, the M
Lab™ Collaboration Centers are spaces
where customers can visit to see what
technology is available, receive hands-on
experience, and test to see what will work
for their process.
Finally, we offer a wide range of training
for equipment, process strategies, and
manufacturing strategies under different
types of operating conditions. The M
Lab™ Collaboration Centers can be used
by the process development team to train
new hires, and we also see training being
delivered to manufacturing operators.
If speed to market is critical, you don’t
want to have a product approved and
then have a delay in getting the product
manufactured. There have also been
instances where customers come to us
and we work side by side with them to
create and test their process.
Sponsored Feature2
On the Cusp of
Curing Disease
Welcome to the M Lab™
Collaboration Centers – where
customers can use non-GMP lab
spaces to operate equipment,
evaluate processes and receive
real-time technical support
without disrupting production.
With Elizabeth Goodrich and Ranjeet Patil
The life science business of Merck operates as MilliporeSigma in the US and Canada. M Lab is a trademark of Merck, KGaA, Darmstadt, Germany.
All other trademarks are the property of their respective owners. Detailed information on trademarks is available via publicly accessible resources.
3. And how have customers responded
to the M Lab™ Collaboration Centers?
RP: Feedback from customers has been
excellent. Many developers of gene
therapies are still in small research labs
(many have been spun out of academia)
– and the teams often under-estimate the
real difficulties of manufacturing a therapy at
scale.AttheMLab™CollaborationCenters,
the customer brings their understanding of
their product and expectations for scale,
and we contribute our expertise in each unit
operation and our holistic understanding
of the implications of certain processes for
commercial scale manufacturing.
How is MilliporeSigma preparing for
the future?
EG: Gene therapies could dramatically
change world health, and will also cause
a shift for companies like ourselves. We
need to contribute product and application
expertise to ensure that these therapies are
manufacturable to high safety and quality
standards. This also needs to be done in a
cost-efficient manner so that patients can
access these important treatments.
RP: Product and technology innovation
is very important to MilliporeSigma. We
are looking at purpose-built tools for
gene therapy manufacturers, such as
more productive cell lines, more efficient
downstream tools, and the biosafety testing
services to consistently satisfy regulatory
expectations. We are also working to
understand how we can become a
better business partner for gene therapy
developers, as well as other players in the
ecosystem, such as other CMOs.
Elizabeth Goodrich is Director of
Global Applications Engineering within
Manufacturing Sciences and Technology,
and Ranjeet Patil is Segment Head,
Vaccines and Viral Therapies, both at
MilliporeSigma.
Heading to the Clinic
With Michael Mercaldi, Ph.D, Director
Purification Process Development at
Homology Medicines.
Homology Medicines is a gene therapy
and gene editing company that was
started based on the discovery of 15
novel adeno-associated viruses (AAV)
naturally found in human hemopoietic
stem cells (AAVHSCs). This set of novel
serotypesenablestheselectionofoptimal
AAVHSC capsids for genetic medicines
that exhibit differentiated biodistribution,
lower immunogenicity and enhanced
potency compared to other AAV
serotypes. We have discovered that
AAVHSCs can perform nuclease-free
gene editing in addition to gene transfer.
The gene editing capability of these AAVs
was shown to harness the mechanism
of homologous recombination, the
body’s natural DNA repair process.
This is different than other gene editing
technologies (i.e., CRISPR, ZFNs, etc.),
which require a nuclease to cut the DNA
and, in doing so, promote another DNA
repair pathway called non-homologous
end joining, or NEHJ, a more common
yet error prone process. Homologous
recombination-based gene editing has
shown to be highly efficient and precise,
and utilizes a single component system
(i.e., one vector, one construct), making
it a more straightforward method.
Currently, we are moving toward
the clinic with our lead gene therapy
construct, HMI-102. HMI-102 is
designed to treat and potentially cure
phenylketonuria (PKU) in adult patients.
There are many challenges in the
gene therapy space. Leveraging the
industry’s experience with proteins
(mAbs) is a great start to manufacturing
gene therapies, but it’s insufficient,
and in some cases provides counter-
productive directions. Unlike mAbs
and recombinant proteins, where
there is a 30 to 40-year bedrock of
understanding on how to efficiently
and effectively design and produce
these therapies, the industry is only
just beginning to learn how to do this
with AAVs. To this, we feel that the
big drivers to advance the field are to
increase upstream and downstream
productivity, develop more in-depth
analytical methods, and to drive
development of more specific AAV
raw materials and equipment.
At Homology, we are building our
own internal process development and
GMP manufacturing capabilities and to
this point we understand that it requires
collaboration among Homology and
key partners to solve the challenges
in this field. We decided to visit the
M Lab™ Collaboration Center this
year to work with MilliporeSigma
on developing some of our platform
manufacturing processes for our AAV
therapies. We found MilliporeSigma to
be extremely helpful with identifying
equipment and consumables that we
are testing and may want to implement
in our new facility. Their expertise and
openness toward collaboration has
been very valuable for us as we build
out our pipeline and capabilities.
“Single use is a
great option for
gene therapy
manufacturers.”
Sponsored Feature 3