Guest Columns
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A Novel Approach To Managing Risks In Aseptic Processing Of Cell & Gene Therapies
2/21/2024
Establishing a robust contamination control strategy for advanced therapy medicinal products, also referred to as cellular and gene therapy products, is of utmost importance. We must employ risk assessments and risk-based approaches. In this article, the authors introduce the aseptic risk evaluation model (AREM), which is compliant with the evolving global regulatory landscape and best practices.
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Developing & Implementing A Continuous Bioprocess Control Strategy
2/20/2024
A key challenge to better uptake of continuous processes in biologics manufacturing is the necessity to link unit operations. This article defines a standard template approach for developing and implementing a continuous bioprocessing control strategy, providing a visual and technical aid, and sharing considerations when selecting control schemes.
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A Data-Derived Approach For Selecting Criticality Levels In FMECAs For Cleaning Process Risk Analysis
2/16/2024
The ASTM E55 Cleaning Team, in collaboration with F04 Medical Device Committee members, felt that the commonly used three-level criticality system was inadequate for use in a science- and risk-based standard for cleaning process development, validation, and monitoring. This article will provide a detailed discussion of how science-based and data-driven criticality levels were derived, the meaning of each level, and how they can be used for guiding the selection of risk reduction and risk control measures.
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Let’s Clean Up That Bioburden — The Aseptic Suite’s Persistent Plague
2/16/2024
After decades of helping to rescue biotech and pharma companies from environmental monitoring excursions, Herman and Erich Bozenhardt bring this discussion about specific problems you should avoid.
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FDA’s CBER Issues Final Guidance For CAR T Cell Products
2/15/2024
The FDA issued the final guidance document, Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products, on January 29. This article shares a useful and thorough summary of the guidance and where it differs (or not) from the earlier draft version of the guidance.
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New DSCSA Guidance Details Layers Of Verification System Requirements
2/15/2024
A recent FDA final guidance interpreting the DSCSA details verification systems expectations for trading partners. Just how they should meet these expectations, however, remains unclear.
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Using Relational Risk Analysis To Control Procedure Failures
2/15/2024
In the bio/pharma and medical device industries, operating procedures guide virtually every activity and are required for compliance with good manufacturing practices. Minimizing procedure execution failures is critical. To do so, you can use relational risk analysis (ReRA).
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Getting Generic Drugs Right: FDA Revises ANDA Guidance
2/14/2024
To improve the quality of abbreviated new drug applications (ANDAs) and to ensure improved consistency, the FDA has developed a new guidance to assist applicants in preparing and submitting amendments to tentatively approved ANDAs or in seeking final approval. This new guidance replaces the previous September 2020 version.
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Stable Cell Lines: Stepping Stones For Continuous Viral Vector Manufacturing
2/14/2024
Amid the increasing need for greater volumes of therapeutic molecules, proteins, and viral vectors, a promising technology started to develop — the stable cell line.
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Assessing Cross Contamination Using Layers Of Protection Analysis For Facility And Product Safety
2/14/2024
Layers of protection analysis (LOPA) is a risk tool that focuses on the strength of controls that are currently in place and enables a cross-functional team to dive into the ways that the controls may fail. The article outlines the application of LOPA to drug product and facility cross contamination.