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.
Latest Updates in Biosafety Testing for Gene TherapyMilliporeSigma
The field of Gene Therapy is moving at a fast pace providing promise of lifesaving medicines to previously unmet clinical needs. Of significant importance in the development of these novel therapies is the ability to demonstrate their safety including freedom from adventitious agents originating from raw materials or introduced during the manufacturing process.
It can be challenging, in such a fast moving field, to identify and navigate the relevant regulatory requirements and expectations for biosafety testing of such therapies. So too it can be difficult to select the optimal test methods in light of limited product availability and shelf life. Encompassing current biosafety testing approaches for bacteria, fungi, mycoplasma and viruses on starting materials to drug product, this webinar will provide you with the fundamentals to design your own Gene Therapy testing strategy.
In this webinar, you will learn:
• The most up to date regulatory expectations for Gene Therapies
• How to design a testing strategy to meet US FDA and EMA requirements
• How selecting the right biosafety test can overcome some of the unique challenges with Gene Therapies
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.
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
Webinar: Post Approval Changes in Biologics Manufacturing - A Practical Asses...MilliporeSigma
Participate in the interactive webinar: http://bit.ly/PACWebinar
Post-approval changes for biologics manufacturing processes are complicated and challenging with the current global diverse regulatory environment. Here, we will present approaches to make these changes more efficient using a risk-based approach.
Explore our webinar library: www.emdmillipore.com/webinars
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.
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
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
Latest Updates in Biosafety Testing for Gene TherapyMilliporeSigma
The field of Gene Therapy is moving at a fast pace providing promise of lifesaving medicines to previously unmet clinical needs. Of significant importance in the development of these novel therapies is the ability to demonstrate their safety including freedom from adventitious agents originating from raw materials or introduced during the manufacturing process.
It can be challenging, in such a fast moving field, to identify and navigate the relevant regulatory requirements and expectations for biosafety testing of such therapies. So too it can be difficult to select the optimal test methods in light of limited product availability and shelf life. Encompassing current biosafety testing approaches for bacteria, fungi, mycoplasma and viruses on starting materials to drug product, this webinar will provide you with the fundamentals to design your own Gene Therapy testing strategy.
In this webinar, you will learn:
• The most up to date regulatory expectations for Gene Therapies
• How to design a testing strategy to meet US FDA and EMA requirements
• How selecting the right biosafety test can overcome some of the unique challenges with Gene Therapies
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.
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
Webinar: Post Approval Changes in Biologics Manufacturing - A Practical Asses...MilliporeSigma
Participate in the interactive webinar: http://bit.ly/PACWebinar
Post-approval changes for biologics manufacturing processes are complicated and challenging with the current global diverse regulatory environment. Here, we will present approaches to make these changes more efficient using a risk-based approach.
Explore our webinar library: www.emdmillipore.com/webinars
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.
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
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
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
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.
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
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
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.
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
Identifying Appropriate-Quality Pharmaceutical Raw Materials in an Evolving R...MilliporeSigma
This webinar will discuss appropriate quality attributes for different raw material uses, present strategies to support identification, selection and risk assessment of raw materials, and highlight the importance of regulatory documentation.
Recent and continuing regulatory improvements require drug manufacturers to assess and mitigate risk throughout their entire processes. This includes raw materials used at every stage of manufacturing and clinical phases. Current regulatory guidelines and industry standards clearly define quality requirements for raw materials that are incorporated into, or used close to, final drug product, for example active ingredients and excipients. However, no such clear standards are defined for chemicals used earlier in the process, such as in upstream bioprocessing, early chemical synthesis stages, or clean-in-place. The absence of such standards presents a challenge to efficiently and effectively source raw materials with appropriate supply chain transparency and control, accompanied by the necessary supporting documentation.
In this webinar, you will learn:
• Strategies to support identification, selection, and risk assessment of raw materials throughout the manufacturing process
• Appropriate quality attributes for different raw material uses
• The importance of quality and regulatory documentation provided by the supplier
Key to Successful Formulation Development for Lipid Based RNA Delivery and Va...MilliporeSigma
In this webinar, we will discuss:
• The application of RNA therapeutics and the different drug delivery routes used in the clinic.
• Design principles for developing lipids-based RNA formulations.
• Critical parameters to consider for cost effective development and consistent performance of RNA therapeutics and vaccines.
RNA therapeutics are changing the way we address diseases. Applications range from gene therapy, oncology, to vaccines for infectious diseases such as COVID-19.
The performance of RNA therapeutics critically depends on its formulation. Key decisions have to be made early on in the drug development process; choosing the appropriate drug delivery method and novel excipients. Raw material source and judicious choice of chemistry, ultimately determine the quality of novel lipid excipients which, in turn, has a big impact on the performance, reproducibility, costs, and regulatory approval timelines. This webinar will propose solutions to maximize the probability of success while formulating RNA therapeutics and vaccines.
Participate in the interactive webinar now: https://bit.ly/2xXMZlm
Explore our webinar library: www.emdmillipore.com/webinars
Watch the on demand webinar here: https://bit.ly/3cHnFzP
All biologics production processes focus on preventing adventitious microorganisms from entering upstream processes. Regulatory guidance for upstream processes focuses on comprehensive testing and characterization of raw materials. While there is no specific mandate for implementing viral clearance technologies, manufacturers are increasingly implementing practices that mitigate the risk of contamination and the consequent disruption to manufacturing operations. This webinar will discuss the potential sources of viral contaminants, the strengths and limitations of different detection and removal technologies and explain how they can be integrated into a comprehensive, holistic, upstream viral safety strategy.
In this webinar, you will learn about:
- How integrating multiple approaches can reduce contamination risks
- Retention performance with different filters for cell culture media processing
Next Generation Bioprocessing adoption for mAbs – BioContinuum™ Platform Info...Merck Life Sciences
Learn more on the opportunities and hurdles of intensified, connected or continuous processing. 30 US and European biomanufacturers were interviewed to understand the likely future adoption of ‘Next Generation Bioprocessing’.
Discover the animated version! http://www.merckmillipore.com/INTL/en/20180329_155610?bd=1&tab=2
Visit the BioContinuum™ Platform webpage now! http://www.merckmillipore.com/biocontinuum
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
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.
Streamlining Biopharmaceutical Cell Line Development - Reducing risk and decr...Merck Life Sciences
CHO cells with their unique characteristics, represent the major expression system within the biopharmaceutical industry. However, one of the major challenges in cell line development is to identify those rare, high-producing clones in a huge population of non-expressing or low-expressing cell lines. This leads to laborious and time consuming cell line development processes. This webinar will educate the audience about challenges faced with traditional expression systems and how the CHO cell line with the glutamine synthethase knock-out via Zinc Finger Nucleases provides benefits for fast and efficient cell line development as well as stable and high titer expression. We will explore additional cell line engineering targets that can be modified to engineer a cell line that mitigates risks and removes bottlenecks throughout the biopharmaceutical process.
In this webinar, you will learn:
• What are the benefits of using an optimized/engineered expression system?
• What can be done throughout the cell line development process to mitigate risks and remove bottlenecks?
• Applications of cell line engineering for further upstream biopharmaceutical enhancements.
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.
The Emprove® Program: Introduction of New Portfolio AdditionsMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3wT5Irt
The Emprove® Program is constantly expanding and updating. Find out about the recently launched Emprove® CCM category for our cell culture media portfolio, the new Emprove® API Information Packages, and the latest updates on available TUPPs for our Emprove® Chemicals portfolio.
This virtual user group will introduce the two latest additions to the Emprove® Program:
1. Our latest category Emprove® CCM for our cell culture media with wave 1 focus on our Cellvento® CHO cell culture media portfolio, looking also into the content of our three Emprove® Dossiers.
2. The new Emprove® API Information Packages that are currently created for our Emprove® APIs, looking into the content and showing how to access.
Additionally, we'll give an overview of latest Technically Unavoidable Particle Profiles (TUPPs) for our Emprove® Chemicals.
In this virtual user group, you will learn:
• Emprove® CCM and its documentation for our cell culture media
• Content and availability of the new Emprove® API Information Package
• Update on available TUPPs for our Emprove® Chemicals
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
Viral clearance is a critical component of regulatory submissions as it helps demonstrate overall product safety . Laboratory scale-down models validate your downstream purification process for removal/inactivation of adventitious agents. The design of an effective viral clearance platform is essential for continual success. WuXi Advanced Therapies has the right experience for the nuanced world of viral clearance and a platform to drive higher log reduction values (LRV).
Cell & Gene Therapy enterprise development solutions to reduce scientific, regulatory and commercial risks, and accelerate development wherever you are in your product's development.
Cell & Gene Therapy enterprise development solutions to reduce scientific, regulatory and commercial risks, and accelerate development wherever you are in your product's development.
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
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.
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
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
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.
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
Identifying Appropriate-Quality Pharmaceutical Raw Materials in an Evolving R...MilliporeSigma
This webinar will discuss appropriate quality attributes for different raw material uses, present strategies to support identification, selection and risk assessment of raw materials, and highlight the importance of regulatory documentation.
Recent and continuing regulatory improvements require drug manufacturers to assess and mitigate risk throughout their entire processes. This includes raw materials used at every stage of manufacturing and clinical phases. Current regulatory guidelines and industry standards clearly define quality requirements for raw materials that are incorporated into, or used close to, final drug product, for example active ingredients and excipients. However, no such clear standards are defined for chemicals used earlier in the process, such as in upstream bioprocessing, early chemical synthesis stages, or clean-in-place. The absence of such standards presents a challenge to efficiently and effectively source raw materials with appropriate supply chain transparency and control, accompanied by the necessary supporting documentation.
In this webinar, you will learn:
• Strategies to support identification, selection, and risk assessment of raw materials throughout the manufacturing process
• Appropriate quality attributes for different raw material uses
• The importance of quality and regulatory documentation provided by the supplier
Key to Successful Formulation Development for Lipid Based RNA Delivery and Va...MilliporeSigma
In this webinar, we will discuss:
• The application of RNA therapeutics and the different drug delivery routes used in the clinic.
• Design principles for developing lipids-based RNA formulations.
• Critical parameters to consider for cost effective development and consistent performance of RNA therapeutics and vaccines.
RNA therapeutics are changing the way we address diseases. Applications range from gene therapy, oncology, to vaccines for infectious diseases such as COVID-19.
The performance of RNA therapeutics critically depends on its formulation. Key decisions have to be made early on in the drug development process; choosing the appropriate drug delivery method and novel excipients. Raw material source and judicious choice of chemistry, ultimately determine the quality of novel lipid excipients which, in turn, has a big impact on the performance, reproducibility, costs, and regulatory approval timelines. This webinar will propose solutions to maximize the probability of success while formulating RNA therapeutics and vaccines.
Participate in the interactive webinar now: https://bit.ly/2xXMZlm
Explore our webinar library: www.emdmillipore.com/webinars
Watch the on demand webinar here: https://bit.ly/3cHnFzP
All biologics production processes focus on preventing adventitious microorganisms from entering upstream processes. Regulatory guidance for upstream processes focuses on comprehensive testing and characterization of raw materials. While there is no specific mandate for implementing viral clearance technologies, manufacturers are increasingly implementing practices that mitigate the risk of contamination and the consequent disruption to manufacturing operations. This webinar will discuss the potential sources of viral contaminants, the strengths and limitations of different detection and removal technologies and explain how they can be integrated into a comprehensive, holistic, upstream viral safety strategy.
In this webinar, you will learn about:
- How integrating multiple approaches can reduce contamination risks
- Retention performance with different filters for cell culture media processing
Next Generation Bioprocessing adoption for mAbs – BioContinuum™ Platform Info...Merck Life Sciences
Learn more on the opportunities and hurdles of intensified, connected or continuous processing. 30 US and European biomanufacturers were interviewed to understand the likely future adoption of ‘Next Generation Bioprocessing’.
Discover the animated version! http://www.merckmillipore.com/INTL/en/20180329_155610?bd=1&tab=2
Visit the BioContinuum™ Platform webpage now! http://www.merckmillipore.com/biocontinuum
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
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.
Streamlining Biopharmaceutical Cell Line Development - Reducing risk and decr...Merck Life Sciences
CHO cells with their unique characteristics, represent the major expression system within the biopharmaceutical industry. However, one of the major challenges in cell line development is to identify those rare, high-producing clones in a huge population of non-expressing or low-expressing cell lines. This leads to laborious and time consuming cell line development processes. This webinar will educate the audience about challenges faced with traditional expression systems and how the CHO cell line with the glutamine synthethase knock-out via Zinc Finger Nucleases provides benefits for fast and efficient cell line development as well as stable and high titer expression. We will explore additional cell line engineering targets that can be modified to engineer a cell line that mitigates risks and removes bottlenecks throughout the biopharmaceutical process.
In this webinar, you will learn:
• What are the benefits of using an optimized/engineered expression system?
• What can be done throughout the cell line development process to mitigate risks and remove bottlenecks?
• Applications of cell line engineering for further upstream biopharmaceutical enhancements.
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.
The Emprove® Program: Introduction of New Portfolio AdditionsMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3wT5Irt
The Emprove® Program is constantly expanding and updating. Find out about the recently launched Emprove® CCM category for our cell culture media portfolio, the new Emprove® API Information Packages, and the latest updates on available TUPPs for our Emprove® Chemicals portfolio.
This virtual user group will introduce the two latest additions to the Emprove® Program:
1. Our latest category Emprove® CCM for our cell culture media with wave 1 focus on our Cellvento® CHO cell culture media portfolio, looking also into the content of our three Emprove® Dossiers.
2. The new Emprove® API Information Packages that are currently created for our Emprove® APIs, looking into the content and showing how to access.
Additionally, we'll give an overview of latest Technically Unavoidable Particle Profiles (TUPPs) for our Emprove® Chemicals.
In this virtual user group, you will learn:
• Emprove® CCM and its documentation for our cell culture media
• Content and availability of the new Emprove® API Information Package
• Update on available TUPPs for our Emprove® Chemicals
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
Viral clearance is a critical component of regulatory submissions as it helps demonstrate overall product safety . Laboratory scale-down models validate your downstream purification process for removal/inactivation of adventitious agents. The design of an effective viral clearance platform is essential for continual success. WuXi Advanced Therapies has the right experience for the nuanced world of viral clearance and a platform to drive higher log reduction values (LRV).
Cell & Gene Therapy enterprise development solutions to reduce scientific, regulatory and commercial risks, and accelerate development wherever you are in your product's development.
Cell & Gene Therapy enterprise development solutions to reduce scientific, regulatory and commercial risks, and accelerate development wherever you are in your product's development.
Fully-Integrated Services for Global Therapeutics Development: Accelerating Progress and Time to Market with integrated CDMO Platforms and Laboratory Testing Services. WuXi Advanced Therapies leverages decades of laboratory testing experience to get your product to market faster and with greater predictability, by overcoming common industry constraints.
WuXi Advanced Therapies’ combination of flexible service options, advanced capabilities, unmatched expertise and state-of-the-art facilities provides cell therapy clients a distinct advantage: a unique single-source for cellular therapeutics services — from procurement, process development, cell expansion, and fill/finish to comprehensive product testing and release.
Innovative Solutions to Advance Immune-Mediated Inflammatory Disease Drug Dev...Covance
Recent scientific advances have propelled our understanding of the immune system's regulation, as well as identified targets that play key roles in inflammatory and autoimmune diseases. Immune-Mediated Inflammatory Diseases (IMIDs) share common pathways, creating the opportunity to treat multiple inflammatory diseases and improve treatment for millions of people worldwide.
Adherent Lentivirus Suspension Production & Manufacturing.pptxGenScript ProBio
GenScript ProBio is the world's leading biotech company founded in 2002 in New Jersey USA. We at GenScript ProBio provide various solutions based on gene synthesis technology including lentivirus manufacturing, CAR-T IND filing, plasmid manufacturing & production, and many more.
Advance Your Program in China with Fully Integrated Clinical Development Solu...Covance
Meet your needs for greater efficiency, expanded capacity and customized support at the newly opened Covance Drug Development Center in Shanghai, China.
Stabicon has been ambitiously established in 2010. Professionally managed with 75 scientists from diverse background expertise. Our organization is specialized in managing product quality process, upgrading and introducing advanced technology into products. we are proud to lay a foundation for prosperous future in prevention and cure segment, future medicine & FMCG business.
Validation of an Off-the-Shelf, Diet-Induced NASH Mouse Model using Digital Whole Slide Scanning of Liver Tissue and Artificial Intelligence-Enabled, Quantitative Histopathological Analysis
Regulatory agencies worldwide require a continuing and well-controlled supply of the specific cell lineage that is integral to the manufacturing process of a biopharmaceutical. Let WuXi Advanced Therapies’ team of experienced cell culture specialists – with the oversight of our highly trained quality assurance unit – manufacture your banks to the highest standards to meet global expectations.
Defined, consistent quality: The only all-in-one solution to simplify algae engineering:
GeneArt® Algae Engineering Kits for rapid production. Previously, algae research and production labs relied on poorly characterized, non-optimized cell stocks and cloning tools for their work. Preparing growth medium was convoluted and time-consuming, and growth rates and yields from the transformed cells were disappointing. New GeneArt® Algae Engineering Kits for Chlamydomonas reinhardtii and Synechococcus elongatus are the first commercially available genetic modification and expression systems for photosynthetic microalgae. These kits are designed for rapid scale-up and production and consistent, defined quality.
CC3TM:A Stable,Sterile Analog of Poly-D-Lysine that is Optimal for the Cultur...Daniel Schroen, PhD
Poly-D-Lysine (PDL) improves attachment and growth of certain fastidious cells. PDL surfaces cannot be considered formally sterile, because current sterilization methods would compromise cell adhesion and often require controlled storage conditions over the usual 1-2 year shelf life. To address these issues, a non-biological analog of PDL was investigated for function and stability in cell culture. This synthetic organic polymer, CC3TM, displays a high amine group density and positive charge in neutral media.
Cell Applications, Inc. is a leading authority and global provider of primary human and animal cell types, complimented by optimized media and cell biology products to serve your research & development goals. Primary Cells, derived directly from tissue, maintain physiological relevance and find increasing use in life science research and pharmaceutical drug discovery. In business since 1994, we have perfected the isolation, purification, subculture and growth of human and animal primary cells. Available options include proliferating or cryopreserved cells, 3D models, 96 well plated versions, disease models, or cells pre-screened for metabolic regulation markers and signal pathways.
News, Events, Publications, Videos, Trends, Frequently Asked Questions, Innovation and Technology - All surrounding the field of Primary Cells, used in disease research and drug discovery.
Preventing Cell Culture Contamination with Copper CO2 IncubatorsDaniel Schroen, PhD
A CO2 incubator provides an excellent growth environment for cell cultures. However, the same warm, humid conditions can also sustain the growth of contaminating microorganisms. From easy-to- clean design to external water reservoirs and heat decontamination cycles, Thermo Scientific Heracell ® CO2 incubators are
proven to prevent and eliminate contamination.
Using the Thermo Scientific Sorvall® WX Ultracentrifuge to Isolate Skeletal M...Daniel Schroen, PhD
Ultracentrifugation is commonly employed to isolate membrane fractions in sucrose gradients. In order to prepare skeletal muscle membranes for cell biology studies, the Thermo Scientific Sorvall WX ultracentrifuge can be used.
Life Technologies (now Thermo Fisher Scientific) combines next-generation sequencing, in silico gene design and synthesis, synthetic biology products, and manufacturing capabilities to form a comprehensive synthetic vaccine development workflow.
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
Anti ulcer drugs and their Advance pharmacology ||
Anti-ulcer drugs are medications used to prevent and treat ulcers in the stomach and upper part of the small intestine (duodenal ulcers). These ulcers are often caused by an imbalance between stomach acid and the mucosal lining, which protects the stomach lining.
||Scope: Overview of various classes of anti-ulcer drugs, their mechanisms of action, indications, side effects, and clinical considerations.
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
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Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
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2. 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.
complex & evolving
environment
The regulatory pathway for gene therapies
is complex and time-intensive. As the
global market rapidly expands, the
interpretation of regulations continues
to evolve, which is why careful planning
of your safety testing program will always
be crucial to clinical success.
3. WuXi Advanced Therapies' integrated approach
to gene testing program design
Building the right safety testing program
requires expertise and experience in a broad
range of disciplines, including virology,
molecular biology and cell-based techniques.
meeting your challenges
Testing plan design
Custom assay development
Multiple testing methodologies
Phase-appropriate validation
Integrating data packages
Meeting aggressive milestones
Understand the goal
timelines, deliverables
Understand the product
vectors, cell lines, clinical phase
Customize to unique needs
standard or custom assays
Navigate regulatory environment
phase-specific requirements
Provide trouble-shooting
Communicate timely updates
dedicated project management
Generate high-quality data
Perform thorough data review
Deliver interpretative reports
Provide comprehensive regulatory support
4. Our state-of-the-art facilities provide adaptable
manufacturing and testing solutions utilizing our
integrated services. We have the capacity to support
any program from early to late stage, with the
additional resources needed to support commercial
volumes.
Our viral vector experience is second to none, and
includes the following:
• Adeno-Associated Virus (AAV) • Adenovirus
• Lentivirus • Retrovirus
Gene Therapies Testing & Manufacturing
Discovery Clinical / CommercialPre-Clinical / Development
In-Vivo
Testing
Testing
Cell & Virus
or Plasmid
Assay
Development
Safety
–––––––
Toxicology
–––––––
Biodistribution
Upstream /
Downstream
Process
Development
Custom
Assay
Development
Small-Scale
Manufacturing
Scale-Up /
Process
Optimization
Process & QC
Analytical
Validation
cGMP
Manufacturing
Product
Release /
Stability
Testing
Patient
Monitoring
Analyses
experience
Ever since the first clinical gene therapy
programs were initiated, WuXi Advanced
Therapies has been providing the technical
testing competencies and regulatory
expertise to help navigate novel biologics
from development through to late-stage
clinical trials — supporting hundreds of
successful regulatory submissions.
WuXi Advanced Therapies offers a fully integrated set of services
to support development and manufacturing of your gene therapy
product — from concept to commercialization.
WuXi Advanced Therapies’unmatched preclinical
services for gene therapy products leverage our
unique mix of scientific and regulatory expertise
in virology, bioanalytical assays and other studies.
Our staff experience, state-of-the-art facilities, and
broad understanding of advanced therapeutic
development will support your IND.
Exceptional Preclinical
Expertise
With decades of experience in biotherapeutics
testing, WuXi Advanced Therapies offers
unparalleled capacity and guidance to reduce
time to clinic. We provide the full spectrum of
testing services, including custom assay
development. As a unique single-source, fully
integrated CDMO, we support gene therapy
products from procurement to comprehensive
product testing for safety, stability and release.
Advanced Testing
Capabilities
Flexible, Commercial-Capacity
Facilities
Extensive Viral Vector
Experience
Services for Gene Therapies
Features of our process development services include:
• Dedicated specialists with pharma experience
• Programs from pre-clinical to commercial
• Upstream and downstream optimization
• Form and fill
• Scale up and scale out
Process Development
Our GMP manufacturing program provides speed and
reliability to support the rapid advance of client
timelines. We offer:
• Dedicated suites
• Clinical and commercial package options that scale
• SUS capability
• Cross-trained staff
• Coverage 7 days a week across multiple shifts
GMP Manufacturing
5. Our state-of-the-art facilities provide adaptable
manufacturing and testing solutions utilizing our
integrated services. We have the capacity to support
any program from early to late stage, with the
additional resources needed to support commercial
volumes.
Our viral vector experience is second to none, and
includes the following:
• Adeno-Associated Virus (AAV) • Adenovirus
• Lentivirus • Retrovirus
Gene Therapies Testing & Manufacturing
Discovery Clinical / CommercialPre-Clinical / Development
In-Vivo
Testing
Testing
Cell & Virus
or Plasmid
Assay
Development
Safety
–––––––
Toxicology
–––––––
Biodistribution
Upstream /
Downstream
Process
Development
Custom
Assay
Development
Small-Scale
Manufacturing
Scale-Up /
Process
Optimization
Process & QC
Analytical
Validation
cGMP
Manufacturing
Product
Release /
Stability
Testing
Patient
Monitoring
Analyses
experience
Ever since the first clinical gene therapy
programs were initiated, WuXi Advanced
Therapies has been providing the technical
testing competencies and regulatory
expertise to help navigate novel biologics
from development through to late-stage
clinical trials — supporting hundreds of
successful regulatory submissions.
WuXi Advanced Therapies offers a fully integrated set of services
to support development and manufacturing of your gene therapy
product — from concept to commercialization.
WuXi Advanced Therapies’unmatched preclinical
services for gene therapy products leverage our
unique mix of scientific and regulatory expertise
in virology, bioanalytical assays and other studies.
Our staff experience, state-of-the-art facilities, and
broad understanding of advanced therapeutic
development will support your IND.
Exceptional Preclinical
Expertise
With decades of experience in biotherapeutics
testing, WuXi Advanced Therapies offers
unparalleled capacity and guidance to reduce
time to clinic. We provide the full spectrum of
testing services, including custom assay
development. As a unique single-source, fully
integrated CDMO, we support gene therapy
products from procurement to comprehensive
product testing for safety, stability and release.
Advanced Testing
Capabilities
Flexible, Commercial-Capacity
Facilities
Extensive Viral Vector
Experience
Services for Gene Therapies
Features of our process development services include:
• Dedicated specialists with pharma experience
• Programs from pre-clinical to commercial
• Upstream and downstream optimization
• Form and fill
• Scale up and scale out
Process Development
Our GMP manufacturing program provides speed and
reliability to support the rapid advance of client
timelines. We offer:
• Dedicated suites
• Clinical and commercial package options that scale
• SUS capability
• Cross-trained staff
• Coverage 7 days a week across multiple shifts
GMP Manufacturing
6. WuXi Advanced Therapies offers a
broad selection of routinely performed
assays and the additional expertise to
develop and validate new custom
assays for your unique programs.
As a leader in gene therapy services, WuXi
Advanced Therapies provides complete support
for your gene therapy program at every stage of
development.
We offer testing services to support programs
in pre-clinical preparation for IND, and phase-
appropriate testing for clinical development,
stability and lot release. Our technical and
regulatory experts are available to design the
right testing program for your unique product.
standard
assays
Leveraging our experience in gene therapy testing,
WuXi Advanced Therapies has developed and
validated a broad selection of routinely performed
standard assays to support gene therapy programs.
These assays are effective and ready to use, saving
time and money compared to developing a new
assay from scratch. Our standard assays include a
complete range of residuals tests to monitor
by-products of the manufacturing process during
development and for lot release. These assays cover
everything from specific host cell proteins and DNA
to leached affinity column ligands, as well as empty
to full ratios of capsids.
Preclinical Services
DNA Sequencing
Raw Material Testing
Efficacy and tK/pK Studies
Risk Assessment
Extractables / Leachables Testing
Toxicology
Dose Finding (MTD) | Subacute | Subchronic | Chronic
Biodistribution
Viral vectors | Human cells
Tumorigenicity
Model development | ESC | iPSC | Adult SC | Cell lines
GMP Cell Banking & Characterization
Viral Bank Safety & Characterization
Viral Clearance
7. custom
assays
Because every product is different, development of
custom assays is often still required for critical testing
that addresses unique aspects of your gene therapy.
Our technical staff has the expertise to rapidly design,
develop and validate these technically challenging
assays – such as product-specific potency assays – to
keep your program moving forward. Semi-custom
assays – such as capsid identity or purity and genome
copy number – can also be validated without lengthy
transfer or development times.
Testing and Release of
GMP Vector Lots
General Characteristics
pH | Appearance | Osmolality
Content / Dose
Viral particle concentration
Vector genome titer
Vector Infectious titer by TCID50
Potency
Custom cell-based gene expression (FACS, ELISA, PCR)
Purity and Identity
Capsid protein identity and purity
Detection of Non-Packaged Transgene DNA
Residuals:
HEK293 Protein
Infectious helper virus
Host cell DNA by qPCR
Benzonase
AVB Resin
Leached Camelid Antibody Fragment
Aggregation by Dynamic Light Scattering
Total Protein Concentration
Empty:Full Capsid (OD 260/280)
Aggregation
Particulates
Purity by SDS-PAGE
Safety
Vector Genome Sequencing
Replication-competent virus: rcAAV, RCL, RCR, RCA
In vitro assay for adventitious viral contaminants
Sterility | Mycoplasma | Endotoxin | Bioburden
Patient Monitoring Testing
In vivo transgene expression | In vivo vector persistence
Custom Assays Include:
Genomic Copy by qPCR
Transgene Expression
Potency Assays
Capsid Protein Identity
Capsid Protein Purity
Infectivity & Expression Assays
Viral Clearance Validation for Clearance
of Helper Viruses
8. The Advanced Therapies business unit of WuXi AppTec is a
global Contract Development and Manufacturing Organization
dedicated to accelerating and transforming development, manufacturing,
and commercialization of cell, gene, and other advanced therapies.
Accelerating Progress
and Time to Market
Integrated CDMO and Testing Service Platform
advancedtherapies.com
CONNECT WITH US
WuXiATU-107-1110118