Guest Columns & From The Editor
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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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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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Addressing The GMP Skills Shortage With Virtual Reality
2/14/2024
In the U.K., a professor at the University of Birmingham is using virtual reality (VR) to help address the growing biomanufacturing skills shortage — using virtual reality (VR).
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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.
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Trends In FDA FY2023 Inspection-Based Warning Letters
2/13/2024
The U.S. FDA issued 180 warning letters to drug and biologics manufacturers in fiscal year 2023 (FY23) and 94 of them were based on an on-site inspection of the company. This article provides an analysis of trends and observations from the inspection-based letters, as well as additional insight on the agency’s approach to enforcement.
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1 In 300 People In The U.S. Is Living With HIV. That’s Not Okay With Jeff Galvin.
2/12/2024
By modifying CD4 T cells using miRNA, Jeff Galvin’s company thinks it can deliver a functional cure for HIV. Here’s the ongoing story of Addimmune and its unique clinical strategy.
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What Does The Catalent Acquisition By Novo Holdings Mean For The Biopharma Industry?
2/12/2024
Novo Holdings, the parent company to Novo Nordisk, announced a deal last week to acquire Catalent, the global CDMO, at a value of $16.5bn. In the same breath, Novo Holdings announced they will sell three sites directly to Novo Nordisk, implying that the rest of the assets of the company will continue to operate as a stand-alone CDMO. This article unpacks the acquisition, discussing questions such as “what does it mean for customers?” and “does this deal reshape the CDMO market?”
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2024’s Market Outlook For Cell & Gene Therapies
2/9/2024
RSM is back for the third consecutive year to provide an outlook analysis of the cell and gene therapy market. This article discusses the 2024 state of the macroeconomy, its effects on cell and gene therapy companies, growing approval pipelines and approvals, funding factors, and the unique prospects for the market.