A Molecule’s Journey – Breaking Down Roadblocks to Commercial Success
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Every biopharma executive must make important decisions early in clinical development that will impact their molecule’s journey – and ultimately the success of their commercial strategy. The key to this success is to make the right decisions at the right time. In this webinar, our experts share some key considerations to help biopharmaceutical companies successfully advance a molecule from the laboratory to the clinic as quickly as possible without sacrificing product quality, process efficiency, or patient safety. To achieve this goal, companies must navigate the complexities associated with business planning, cell line development, process development, technology, and regulatory and risk assessment. In this webinar, you will learn: - Key business considerations for commercial success - Key technical considerations - Regulatory and risk assessment considerations
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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
Simplexity Biotech Consortium
Presentation given by Panel of experts in the development and manufacturing of laboratory instrumentation and medical devices. Event was held May 29th at CG Life facilities in San Diego
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From preclinical to commercial: The evolution of ADC manufacturing expertise ...
ADCs have evolved since the initial approval of MYLOTARG® in 2000, with respect to both conjugation, linker and toxin chemistries as well as processing. With the current availability of four commercially approved drugs and approximately 80 programs in various clinical trials, there has been a significant interest in simplifying the complex supply chain to make manufacturing efficient. With approximately 80% of the programs outsourced to Contract Development and Manufacturing Organizations (CDMOs), a transparent and integrated supply chain is critical for the success of ADC projects.
MilliporeSigma has been involved with the development and manufacturing of ADCs since 2008. This webinar will discuss how chemistry and manufacturing have evolved over the past 10 years globally and how MilliporeSigma, as a CDMO has adapted to these changes to meet customers needs.
In this webinar, you will learn:
● How ADC manufacturing has evolved over the past decade
● The challenges that this evolution implies
● Why an integrated supply chain has become increasingly important for the success of ADC projects
Process Development for Cell Therapy and Viral Gene Therapy
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: Benefits of Monodisperse Activated PEGs in ADC Development
Watch the webinar here: http://bit.ly/PEGsWebinar
As the field of antibody-drug conjugation chemistry has advanced, the use of linkers to impart "drugability" has also been growing. Recent literature shows a variety of linear and branched monodisperse PEGs being called on to modify the PK/PD profile of some of the most active but lipophilic payloads. In this webinar, we will survey the types of PEGs that are used in ADCs and give examples of successful implementation to change the biophysical properties of the construct. In addition, we will focus on PEGs and why activated PEGs are widely used to improve the pharmacokinetics of drugs (such as pegylated proteins, peptides etc.). Raw materials used in this field may have a variety of polydispersity. However, when it comes to the use of activated PEGs as linkers for ADCs, the requirements are significantly higher. Therefore, the choice and control of the PEG linker is crucial for the successful development and accelerated time to market for your ADC.
This webinar addresses critical success factors such as:
• Survey of current PEG enhanced ADCs
• Why PEGs are used designing ADCs
• Critical parameters for aPEGs used as linkers
• Requirements in terms of analytical capabilities
Employing Innovative Platform Manufacturing and Biosafety Testing for your Ge...
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
Accelerating COVID-19 Therapies: How a streamlined biosafety strategy can get...
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.
Overview of Global Regulatory Affairs for Gene Therapy 2019
Presented by:
Mridula Shukla
Regulatory Affairs Global Lead
Author: RAPS study-guide for Global RAC
“International Regulatory Affairs (Chapter on Orphan Drugs)”
Webinar: How Biosafety Testing will Evolve to Meet the Needs of Biologics Man...
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
USP <665> draft standard : A rational risk-based approach to characterization...
This webinar will cover risk-based characterization of filters and single-use systems used in biopharmaceutical manufacturing according to USP <665>.
Novel innovative biomanufacturing systems such as single-use assemblies often comprise of polymeric materials. There is a lack of standards for characterization of these polymeric systems. USP <665> draft standard is the first standard in development addressing this topic. This chapter recommends risk assessment with respect to patient safety, risk level assignment and risk level appropriate characterization of components.
In this webinar we will discuss:
● Risk assessment to assign a risk level
● Risk level based testing
● Our approach for compliance
● Emprove™ Dossiers for Filters and Single-use systems
Next Generation Bioprocessing adoption for mAbs – BioContinuum™ Platform Info...
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
An Integrated Approach to Ensure Viral Vector and Gene Therapy Commercial Rea...
Come learn more about our integrated approach to ensure viral vector and gene therapy commercial readiness. We will discuss topics relating to process development for viral vector manufacturing, biosafety testing and commercial readiness.
Significant progress has been made for the use of viral vectors for gene therapy. Promising clinical trial results as well as recent FDA approval for CAR-T cell therapy to treat certain children and young adults with B-cell lymphoblastic leukemia have signaled advancements in the field. This marks a historic action, providing opportunities for new viral vector technologies to transform medicine and the way patients are treated and even cured. The need for process development for viral vector manufacturing to improve yield to meet patient demand, biosafety testing for product characterization, potency and safety and commercial readiness to accelerate therapy to-market are critically important. Here, we emphasis an integrated approach that allows our customers solutions to ensure viral vector and gene therapy commercial readiness to meet the growing market need.
In this webinar, you will learn:
● Process development advances for production scale-up of viral vectors for gene therapy
● Methods specific for viral gene therapy product characterization, purity, potency, safety and release testing
● Commercial readiness through our US and UK Centers of Excellence for viral product manufacturing
Strategic Considerations for Implementing Single-Use Technologies in Vaccine ...
Strategic Considerations for Implementing Single-Use Technologies in Vaccine ...Dr. Priyabrata Pattnaik
Presented at DCVMN 15th Annual General Meeting, 27-October-2014 to 29-October-2014. New Delhi, India. The presentation can be downloaded from the following site.
http://www.dcvmn.org/sites/default/private_files/files/Strategic%20Considerations%20for%20Implementing%20of%20SU%20(Pattnaik).pdfPromises and Challenges of Manufacturing and Testing Viral Producer Cell Lines
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 BioTherapy
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
Successful Drug Development with Synthetic Lipids: Critical Aspects and Strat...
Lipid-based formulations and lipid nanoparticles are administration strategies of increasing importance in the pharmaceutical world. On the way to a successful drug product registration, there are numerous challenges to be overcome – from formulation development to meeting regulatory requirements and submission. In particular, care must be taken to choose appropriate lipids with respect to their type, source and quality, as these factors greatly affect the performance of the final formulation and also play a role in financial considerations.
In this webinar, you will:
● Explore critical aspects relating to synthetic lipids as raw materials for lipidic formulations
● Learn strategies to minimize risk when choosing lipidic raw materials for drug product development
● Gain insights into tailored manufacturing and lipids with optimized properties such as conjugation of targeting moieties
Gene Therapy Services
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.
Upcoming USP 665 - Level of Characterization of Single-Use Systems Today and ...
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
Process equipment characterization – how standardized extractables data suppo...
View the recording here: https://bit.ly/35KIwBb
Biopharmaceutical Industry recently increased adoption of Single-Use systems and components in manufacturing process operations. Drug manufacturers are responsible for the characterization of SU components and systems used for the production to ensure patient safety. SUS Suppliers are encouraged by BPOG and BPSA to provide comprehensive extractables data package to support drug manufacturer’s E&L assessments.
This webinar will give an overview of the E&L evaluation workflow and practical study approaches from both supplier and end-user perspective, in accordance with the latest industry’s standards and upcoming USP <665> requirements. Case studies will be presented on how the data from suppliers are used to mitigate risk associated to SU materials, highlighting the key role of collaboration between the supplier and the drug manufacturer.
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From preclinical to commercial: The evolution of ADC manufacturing expertise ...
From preclinical to commercial: The evolution of ADC manufacturing expertise ...
Process Development for Cell Therapy and Viral Gene Therapy
Process Development for Cell Therapy and Viral Gene Therapy
Webinar: Benefits of Monodisperse Activated PEGs in ADC Development
Webinar: Benefits of Monodisperse Activated PEGs in ADC Development
Employing Innovative Platform Manufacturing and Biosafety Testing for your Ge...
Employing Innovative Platform Manufacturing and Biosafety Testing for your Ge...
Accelerating COVID-19 Therapies: How a streamlined biosafety strategy can get...
Accelerating COVID-19 Therapies: How a streamlined biosafety strategy can get...
Overview of Global Regulatory Affairs for Gene Therapy 2019
Overview of Global Regulatory Affairs for Gene Therapy 2019
Webinar: How Biosafety Testing will Evolve to Meet the Needs of Biologics Man...
Webinar: How Biosafety Testing will Evolve to Meet the Needs of Biologics Man...
USP <665> draft standard : A rational risk-based approach to characterization...
USP <665> draft standard : A rational risk-based approach to characterization...
Next Generation Bioprocessing adoption for mAbs – BioContinuum™ Platform Info...
Next Generation Bioprocessing adoption for mAbs – BioContinuum™ Platform Info...
An Integrated Approach to Ensure Viral Vector and Gene Therapy Commercial Rea...
An Integrated Approach to Ensure Viral Vector and Gene Therapy Commercial Rea...
Strategic Considerations for Implementing Single-Use Technologies in Vaccine ...
Strategic Considerations for Implementing Single-Use Technologies in Vaccine ...
Promises and Challenges of Manufacturing and Testing Viral Producer Cell Lines
Promises and Challenges of Manufacturing and Testing Viral Producer Cell Lines
Process Impurities: Don’t Let PEI or HCP Derail Your BioTherapy
Process Impurities: Don’t Let PEI or HCP Derail Your BioTherapy
Successful Drug Development with Synthetic Lipids: Critical Aspects and Strat...
Successful Drug Development with Synthetic Lipids: Critical Aspects and Strat...
Upcoming USP 665 - Level of Characterization of Single-Use Systems Today and ...
Upcoming USP 665 - Level of Characterization of Single-Use Systems Today and ...
Process equipment characterization – how standardized extractables data suppo...
Process equipment characterization – how standardized extractables data suppo...
Similar to A Molecule’s Journey – Breaking Down Roadblocks to Commercial Success
Streamlining Biopharmaceutical Cell Line Development - Reducing risk and decr...
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.
Employing Innovative Platform Manufacturing and Biosafety Testing for your Ge...
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
Simplexity Biotech Consortium
Presentation given by Panel of experts in the development and manufacturing of laboratory instrumentation and medical devices. Event was held May 29th at CG Life facilities in San Diego
Optimize Your Process Validation Package
Participate in the full, interactive on-demand webinar here: https://bit.ly/ProcessValWebinar
Process validation is a complex step in the transition to commercial scale manufacturing. While Quality By Design (QBD) is the standard option for a risk-mitigating process validation strategy, there are other options for more flexibility and speed. Join our webinar to learn how outsourcing to a CDMO, able to take an adaptive, risk-based validation approach, will accelerate your time to market.
In this webinar, you will discover more about:
• How outsourcing to a CDMO partner in late-stage will increase flexibility and speed
• How a risk-based approach can help you optimize your process validation strategy
• How we have implemented a risk-based approach for our clients via case studies
DynoChem_webinar_Novartis_Flav_Susanne_11Jun2014
"Application of QbD on a Continuous Process"
Development supported by process simulation.
Flavien Susanne, Chemical Engineer, NOVARTIS
From preclinical to commercial: The evolution of ADC manufacturing expertise ...
ADCs have evolved since the initial approval of MYLOTARG® in 2000, with respect to both conjugation, linker and toxin chemistries as well as processing. With the current availability of four commercially approved drugs and approximately 80 programs in various clinical trials, there has been a significant interest in simplifying the complex supply chain to make manufacturing efficient. With approximately 80% of the programs outsourced to Contract Development and Manufacturing Organizations (CDMOs), a transparent and integrated supply chain is critical for the success of ADC projects.
Merck has been involved with the development and manufacturing of ADCs since 2008. This webinar will discuss how chemistry and manufacturing have evolved over the past 10 years globally and how Merck, as a CDMO has adapted to these changes to meet customers needs.
In this webinar, you will learn:
● How ADC manufacturing has evolved over the past decade
● The challenges that this evolution implies
● Why an integrated supply chain has become increasingly important for the success of ADC projects
Process design focuses on.pdf
Process design focuses on the Multiplication and... Text Structure Work... EC ECmpus: Home
and Work rules; training you use to make things. Technology; work design Training; technology
Technology; work rules 2 Of the four strategies to reduce costs, minimizing work rules and
increasing training to empower workers to find better ways to do things best describes which
strategy? Offshoring Automation Outsourcing Process improvement 3 Economists discuss value
in terms of . Customers talk about value in terms of Value; time and place Dimensions; utilities
Cost and quality: scorecards Utilities: value dimensions 4 An open systems view argues that you
need to recognize be quick to respond, and create more than rivals. Value; products
Opportunities; value Processes; opportunities Success: profits
Which of the following should not influence your choice of technology as you design a
production or service process? Labor cost A desire to buy shiny new hardware Production
volumes Financial resources and are the two types of decisions you need to make to achieve
world-class operations management. Design; control Quality; control Design; quality Human
resource; technology 7 Which of the following approaches can help you mitigate the challenges
of poor forecasts? Minimize inventory Use all the forecasting techniques and average them
together Obtain and use the best, most recent information available Always use simple
forecasting techniques 8 If you want to be taken seriously as a supplier, you have to offer which
two value dimensions? cost and delivery cost and quality innovation and delivery Agility and
innovation
You must meet minimum requirements across which of the five value dimensions? Cost, quality,
and innovation All of them Cost and quality Delivery, and agility 10 Sustained success requires
that you offer distinctive value, so you must differentiate yourself in one of which thare
dimensions? Cost, quality, or innovation Innovation, delivery, or cost Quality, cost, or agility
Agility, innovation, or delivery
Dell pre-orders and stocks up on raw materials and components Purchasing pre-selected pre-
packaged deli meat from a cold case A local coffee shop that prepares coffee or hot beverages
depending on customer orders A customer ordering custom-sliced meat at a deli The difference
between mass production and lean production is that: Mass and lean production utilize both
methods of production based on cost reduction Lean utilizes both "push" and "pull" production
based on customer demand Mass production uses the "push" method, and lean production uses
the "pull" method Mass production uses the "pull" method, and lean production uses the "push"
method 3 A lean system is one that strives to: Lower costs through acquisition of the cheapest
resources available. Minimize the use of resources used to achieve the organization's goals. Offer
a rigid product offering to customers so that operations can be more efficient. Maximize worker
productivity through e.
SMi Group's Pharmaceutical Microbiology USA 2017 conference
SMi Group is launching its Pharmaceutical Microbiology USA 2017 conference in San Diego this June.
Quality by Design Course Preview
Quality by Design is a systematic approach to development that begins with predefined objectives and emphasizes understanding of the product and process, efficient process control, and quality risk management to improve the overall manufacturing quality. Implementing the Quality by Design (QbD) principles in manufacturing has resulted in reduced operating costs, highly efficient manufacturing processes and better positioning companies to meet increasing regulatory expectations.
QbD explains how to prioritize process parameters for screening designs, design robust processes using statistical design of experiments (DoE), bridge the bench and the commercial design spaces using mixing and scale-up calculations, quantify process risk, select suitable process analytical technology tools (PAT) and more.
To know more about Quality by Design training worldwide,
please contact us at -
Email: support@invensislearning.com
Phone - US +1-910-726-3695,
Website: https://www.invensislearning.com
Process Development for Cell Therapy and Viral Gene Therapy
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
Six Sigma Implementation to reduce rejection rate of Pump Casings at local Ma...
Six Sigma is being Implemented all over the World as a successful Quality Improvement
Methodology. This article provides a description of Six Sigma Project implemented at Local manufacturing
Company. The Company Manufactures Pump Casings where it was receiving high nonconformance rate that
resulted in to Rejection of Product. This study deals with Six Sigma DMAIC methodology implementation and
gives a frame work of how the non-conformance rate was first monitored and then brought in to acceptance
limits. A complete Coverage of the statistical analysis performed during the study is given and results are
shown to describe that how Six Sigma helped the Project members to Improve Quality of Pump casings at
manufacturing facility.
6 Tips to Accelerate MedTech Time To Clinical Data
Key Tech saved CoolTech, a startup MedTech company greater than $1 million in development costs and reduced the time required to get to clinical data by six months.
In our newest case study, we outline our expertise in driving speed to clinical data and reducing development costs and time substantially.
USP <665> draft standard : A rational risk-based approach to characterization...
This webinar will cover risk-based characterization of filters and single-use systems used in biopharmaceutical manufacturing according to USP <665>.
Novel innovative biomanufacturing systems such as single-use assemblies often comprise of polymeric materials. There is a lack of standards for characterization of these polymeric systems. USP <665> draft standard is the first standard in development addressing this topic. This chapter recommends risk assessment with respect to patient safety, risk level assignment and risk level appropriate characterization of components.
In this webinar we will discuss:
● Risk assessment to assign a risk level
● Risk level based testing
● Our approach for compliance
● Emprove™ Dossiers for Filters and Single-use systems
Need and Urgency for Harmonization and One Quality Voice
We are in the Experience Economy in which the demand for Assurance is increasing exponentially. Our quality systems are improving linearly, and we are falling behind in delivering the assurance needed by patients to realize therapeutic benefits of medicine we deliver. Industry's need to continually improve is urgent, but their ability to do so remains constrained despite the FDA initiatives. To realize FDA's vision of an agile pharmaceutical manufacturing systems ... Without the need extensive regulatory oversight, industry should be encouraged to "self-author" "performance standards" and regulators should harmonize on the global accessibility of the self-authored performance standards.
#AAPS2017 Need and Urgency for Harmonization and One Quality Voice. A. S. Hussain. Insight, Advice & Solutions LLC.
Similar to A Molecule’s Journey – Breaking Down Roadblocks to Commercial Success (20)
Streamlining Biopharmaceutical Cell Line Development - Reducing risk and decr...
Streamlining Biopharmaceutical Cell Line Development - Reducing risk and decr...
Employing Innovative Platform Manufacturing and Biosafety Testing for your Ge...
Employing Innovative Platform Manufacturing and Biosafety Testing for your Ge...
From preclinical to commercial: The evolution of ADC manufacturing expertise ...
From preclinical to commercial: The evolution of ADC manufacturing expertise ...
SMi Group's Pharmaceutical Microbiology USA 2017 conference
SMi Group's Pharmaceutical Microbiology USA 2017 conference
Process Development for Cell Therapy and Viral Gene Therapy
Process Development for Cell Therapy and Viral Gene Therapy
Six Sigma Implementation to reduce rejection rate of Pump Casings at local Ma...
Six Sigma Implementation to reduce rejection rate of Pump Casings at local Ma...
6 Tips to Accelerate MedTech Time To Clinical Data
6 Tips to Accelerate MedTech Time To Clinical Data
USP <665> draft standard : A rational risk-based approach to characterization...
USP <665> draft standard : A rational risk-based approach to characterization...
Need and Urgency for Harmonization and One Quality Voice
Need and Urgency for Harmonization and One Quality Voice
More from MilliporeSigma
Launch of our new Titanium Dioxide Alternative
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The ideal morphology and particle size for enhanced opacity in tablet coating.
The Viscosity Reduction Platform: Viscosity-reducing excipients for improveme...
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 Purification
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...
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...
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...
Watch the presentation of this webinar: https://bit.ly/3Pjpjvr
Highlights of this webinar:
- Surface plasmon resonance as a powerful tool for biologic characterization including mAbs and ADCs.
- SPR allows rapid binding analysis in real time without using labels for SARS-CoV-2 receptor binding domain mutations.
- Kinetic data is indicative of possible neutralizing activity allowed assessment of neutralizing ability of therapeutic monoclonal antibodies.
- The application can provide preliminarily efficacy information and facilitated mAbs/ACDs candidate selection process
Detailed description:
Characterization of therapeutic monoclonal antibodies (mAbs) or Antibody drug conjugates (ADCs) is challenging due to their ability to bind to a variety of proteins via their Fc and Fab domains, giving rise to diverse biological functions associated with each domain. The Fc domain of mAbs interacts with Fc receptors with varying affinities, which can influence biological processes such as Complement-dependent cytotoxicity (CDC) and Antibody-dependent cellular cytotoxicity (ADCC), transcytosis, phagocytosis, and/or serum half-life.
An important characteristic of an antibody is its Fc effector function. Antibodies can be engineered to obtain desired binding of the Fc region to Fc receptors expressed on effector cells. Hence, it is crucial to evaluate the binding interaction of mAbs/ADC with Fc receptors in the early phase of drug development to understand the potential biological activity of the product in vivo.
Surface Plasmon Resonance (SPR) is a powerful technique to establish binding kinetics in real-time, label free, and high sensitivity with low sample consumption. Along with target antigen binding, it is crucial to evaluate the binding interaction of antibodies and ADCs with Fc receptors. Our SPR case studies investigated the impact on binding kinetics of ADCs with different linkers and the binding interactions of SARS-CoV-2 spike protein variants and evaluated the neutralizing ability of therapeutic mAbs. SPR characterisation can be facilitated in all stages of the product life cycle to ensure the quality and safety of mAbs and ADCs.
The Role of BioPhorum Extractables Data in the Effective Adoption of Single-U...
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 Audits
Watch the recording of this presentation here: https://bit.ly/3zTOpe4
Detailed description:
SARS-CoV-2 showed us that technology supports us during our inspection activity even if on-site visits are not possible. Travel restrictions of various kinds will remain a risk in the future. The use of new technologies has shown that inspections and audits can be carried out despite these restrictions. We will focus on what possibilities the new technologies offer and take a look at the future of inspections and audits.
In this webinar, you will learn:
• Regulatory overview of remote audits
• The technologies needed to support the audit process
• What types of inspections are possible with the use of these technologies
• How audits may look in the future
Presented by:
Daniel Buescher, Product Manager - Digital Solutions
Moving your Gene Therapy from R&D to IND: How to navigate the Regulatory Land...
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 therapies
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...
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...
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?
Watch the presentation of this webinar here: https://bit.ly/3t7X9tg
How does the ICH Q5A revision impact viral safety strategies for biologics?
Biologics continue to grow at a fast pace. Manufactured using cell lines of human or animal origin, these are at risk of viral contamination making safety strategies critical. A comprehensive risk mitigation strategy using multiple orthogonal measures is a regulatory expectation. ICH Q5A, the globally-harmonized guideline outlines the expectations. ICH Q5A is currently being revised to address recent scientific advancements including novel therapeutic modalities, new manufacturing paradigms, updates in viral clearance applications, and alternate detection technologies. We’ll discuss the expected changes and potential impact on viral safety strategies with case studies and examples.
In this webinar, you will learn about:
• The Importance of virus testing in biologics products
• Regulatory landscape, expectations for the Q5A revision
• What's new and changing
• Examples of alternate testing schedules, impact on viral clearance
Presented by:
Manjula Aysola, Senior Regulatory Consultant
Alison Armstrong, PhD, Sr. Director, Technical and Scientific Solutions
Improve Operational Efficiency by Over 30% with Product, Process, & Systems A...
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...
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 Systems
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 ...
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...
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...
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 Therapies
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.
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Use of Excipients in Downstream Processing to Improve Protein Purification
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Exploring the protein stabilizing capability of surfactants against agitation...
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Latest advancements of melt based 3D printing technologies for oral drug deli...
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CAR-T Manufacturing Innovations that Work - Automating Low Volume Processes a...
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How does the ICH Q5A revision impact viral safety strategies for biologics?
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Improve Operational Efficiency by Over 30% with Product, Process, & Systems A...
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Insights from a Global Collaboration Accelerating Vaccine Development with an...
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Risk-Based Qualification of X-Ray Sterilization for Single-Use Systems
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Rapid Replication Competent Adenovirus (rRCA) Detection: Accelerate your Lot ...
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https://pubrica.com/academy/case-study-or-series/how-many-patients-does-case-series-should-have-in-comparison-to-case-reports/
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Health Education on prevention of hypertension
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M Capital Group (“MCG”) predicts that with, against, despite, and even without the global pandemic, the medical technology (MedTech) industry shows signs of continuous healthy growth, driven by smaller, faster, and cheaper devices, growing demand for home-based applications, technological innovation, strategic acquisitions, investments, and SPAC listings. MCG predicts that this should reflects itself in annual growth of over 6%, well beyond 2028.
According to Chris Mouchabhani, Managing Partner at M Capital Group, “Despite all economic scenarios that one may consider, beyond overall economic shocks, medical technology should remain one of the most promising and robust sectors over the short to medium term and well beyond 2028.”
There is a movement towards home-based care for the elderly, next generation scanning and MRI devices, wearable technology, artificial intelligence incorporation, and online connectivity. Experts also see a focus on predictive, preventive, personalized, participatory, and precision medicine, with rising levels of integration of home care and technological innovation.
The average cost of treatment has been rising across the board, creating additional financial burdens to governments, healthcare providers and insurance companies. According to MCG, cost-per-inpatient-stay in the United States alone rose on average annually by over 13% between 2014 to 2021, leading MedTech to focus research efforts on optimized medical equipment at lower price points, whilst emphasizing portability and ease of use. Namely, 46% of the 1,008 medical technology companies in the 2021 MedTech Innovator (“MTI”) database are focusing on prevention, wellness, detection, or diagnosis, signaling a clear push for preventive care to also tackle costs.
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BOWEL ELIMINATION BY ANUSHRI SRIVASTAVA.pptx
Defecation
Normal defecation begins with movement in the left colon, moving stool toward the anus. When stool reaches the rectum, the distention causes relaxation of the internal sphincter and an awareness of the need to defecate. At the time of defecation, the external sphincter relaxes, and abdominal muscles contract, increasing intrarectal pressure and forcing the stool out
The Valsalva maneuver exerts pressure to expel faeces through a voluntary contraction of the abdominal muscles while maintaining forced expiration against a closed airway. Patients with cardiovascular disease, glaucoma, increased intracranial pressure, or a new surgical wound are at greater risk for cardiac dysrhythmias and elevated blood pressure with the Valsalva maneuver and need to avoid straining to pass the stool.
Normal defecation is painless, resulting in passage of soft, formed stool
CONSTIPATION
Constipation is a symptom, not a disease. Improper diet, reduced fluid intake, lack of exercise, and certain medications can cause constipation. For example, patients receiving opiates for pain after surgery often require a stool softener or laxative to prevent constipation. The signs of constipation include infrequent bowel movements (less than every 3 days), difficulty passing stools, excessive straining, inability to defecate at will, and hard feaces
IMPACTION
Fecal impaction results from unrelieved constipation. It is a collection of hardened feces wedged in the rectum that a person cannot expel. In cases of severe impaction the mass extends up into the sigmoid colon.
DIARRHEA
Diarrhea is an increase in the number of stools and the passage of liquid, unformed feces. It is associated with disorders affecting digestion, absorption, and secretion in the GI tract. Intestinal contents pass through the small and large intestine too quickly to allow for the usual absorption of fluid and nutrients. Irritation within the colon results in increased mucus secretion. As a result, feces become watery, and the patient is unable to control the urge to defecate. Normally an anal bag is safe and effective in long-term treatment of patients with fecal incontinence at home, in hospice, or in the hospital. Fecal incontinence is expensive and a potentially dangerous condition in terms of contamination and risk of skin ulceration
HEMORRHOIDS
Hemorrhoids are dilated, engorged veins in the lining of the rectum. They are either external or internal.
FLATULENCE
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FECAL INCONTINENCE
Fecal incontinence is the inability to control passage of feces and gas from the anus. Incontinence harms a patient’s body image
PREPARATION AND GIVING OF LAXATIVESACCORDING TO POTTER AND PERRY,
An enema is the instillation of a solution into the rectum and sig
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Growing Prevalence of Lifestyle Diseases
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A Molecule’s Journey – Breaking Down Roadblocks to Commercial Success
- 1. Guillaume Plane December 2017 Breaking Down Roadblocks to Commercial Success
- 2. 2 A Molecule's Journey Webinar | December 5, 2017 The life science business of Merck KGaA, Darmstadt, Germany operates as MilliporeSigma in the U.S. and Canada.
- 3. A long Journey from decisions to success Key decisions Expected success Business considerations Cell line considerations Process development considerations Regulatory considerations Technology considerations A Molecule's Journey Webinar | December 5, 20173
- 5. 5 A Molecule's Journey Webinar | December 5, 2017 Business considerations Speed to Clinic No revenues before approval Time is money… Key decisions to make over the process Outsource manufacturing to accelerate development? Out-license a molecule to generate revenues before approval? Or internalize 100% to keep the value?
- 6. 6 A Molecule's Journey Webinar | December 5, 2017 Business considerations Process Efficiency over Speed No revenues before approval Time is money… Speed is key but Process efficiency has to be addressed early A poorly developed process can backfire in the later stage Inefficiency can make the drug too expensive to produce Choosing the right partner is key
- 8. 8 A Molecule's Journey Webinar | December 5, 2017 Business considerations Filing Strategy Filing can be either global or local Ease of conducting clinical trials Largest patient populations Time to obtain approval Engage Authorities throughout Development
- 9. 9 A Molecule's Journey Webinar | December 5, 2017 Cell line considerations Choose the right host
- 10. 10 A Molecule's Journey Webinar | December 5, 2017 Cell line considerations Choose the right clone Clonality is a requirement for regulations (ICH Q5D) Protein quality is clone related Robustness is clone related Genetic stability is clone related (60 generations) *Shuangping Shi et al. 2011 Ensure monoclonality thanks to a Clone Select Imager To fit with ICH Q5D
- 11. 11 A Molecule's Journey Webinar | December 5, 2017 Cell line considerations Bank your Clone A Cell Bank ensures robustness over development Cell bank establishment takes 28-30 days Safety testing is a regulatory requirement Cell banking is the first GMP activity
- 12. 12 A Molecule's Journey Webinar | December 5, 2017 Process development considerations Efficiency and Viability Reliable and reproducible through scale-up Reliable and reproducible through scale-down Reliable and reproducible through tech transfer Consider ease of scalability Consider regulatory issues Consider commercial issues
- 13. 13 A Molecule's Journey Webinar | December 5, 2017 Process development considerations Financial viability over Productivity Consider the end-product and its expected cost Cost of raw-materials Upstream titer Downstream efficiency Dose per patient Medical needs Determine the optimal yield of your process Outsource to a trusted partner? Key question
- 14. 14 A Molecule's Journey Webinar | December 5, 2017 Regulatory considerations Patient safety The main driver is to ensure patient safety Prevent safety issues during clinical development Assess product effectiveness Track product isoforms as early as possible Prevent cross-contaminations
- 15. 15 A Molecule's Journey Webinar | December 5, 2017 Regulatory considerations Quality and robustness Product quality Process robustness Analytics Process and Analytical Development HMW Monomer LMW Example: Size Exclusion HPLC
- 16. 16 A Molecule's Journey Webinar | December 5, 2017 Technology considerations Flexibility is key RUN RUN Preparation / Parameter setting Media conditioning CIP and Storage Preparation Preparation / Parameter setting Preparation RUN Stainless Steel Bioreactors Single-use Bioreactors Preparation RUN Single-use as the new Gold standard Elimination of clean-in-place Reduced energy requirement Reduced time requirement Equipment mobility Pre-sterilized assemblies In-process aseptic connections
- 17. 17 A Molecule's Journey Webinar | December 5, 2017 Technology considerations Scalability is key The use of a bioreactor with proven scalability is a way to ensure success through clinical development
- 18. 18 A Molecule's Journey Webinar | December 5, 2017 Conclusion 1. Critical considerations Patient safety Product quality Process efficiency 2. Key considerations Speed to clinic Cost of production
- 19. The life science business of Merck KGaA, Darmstadt, Germany operates as MilliporeSigma in the U.S. and Canada. MilliporeSigma and the vibrant M are trademarks of Merck KGaA, Darmstadt, Germany. Copyright © 2017 EMD Millipore Corporation. All Rights Reserved. BioReliance is a registered trademark of Sigma Aldrich Co LLC. BioReliance is an affiliate of Merck KGaA, Darmstadt, Germany.