BIO From The Editor and Guest Columns
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Risk And Supply Chain Continuity Management: Biologics Industry Perspectives
2/26/2024
We spoke to three long-standing members of BioPhorum’s Risk and Business Continuity Workstream about their companies’ approaches to risk management, supply chain continuity, and what they learned from the pandemic. Among them are Melinda McCants, senior resiliency officer at Amgen.
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Precision Radiopharmaceuticals with Ratio's Jack Hoppin, Ph.D.
2/21/2024
Multimodal approaches to the delivery of radiologically active compounds have created a fertile environment for players in the space to put on a precision medicine clinic, so to speak. What’s more, Radiopharmaceuticals create a unique business opportunity given the closely related and necessary companion diagnostic arena.
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Understanding And Navigating Diverse Regulatory Environments
2/21/2024
Drug developers aspire to treat patients globally, but navigating diverse regulatory structures around the world gets tricky. These consultants offer a primer on the regulatory bodies of the world.
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U.S. Biotech Is In For A Protracted Divorce From China
2/21/2024
The U.S. imported $6.95 billion worth of pharmaceuticals from China in 2022. That was 8x the amount we imported in 2021. A proposed Act of Congress puts that supply, and U.S. biotech itself, in serious peril.
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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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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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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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Managing Mergers With Sail's Guillaume Pfefer, Ph.D.
2/15/2024
While you might be aware that Sail Biomedicines was just formed up in Q4 of last year, the product of Flagship Pioneering’s decision to merge Senda Biosciences and Laronde, two of its programmable medicine platform companies. What you likely haven’t heard is the inside story on how the merger was executed, how the two companies are integrating their talent, IP, and resources, and what Sail Biomedicines CEO Dr. Guillaume Pfefer and team are currently doing to take the fruits of the company’s platform into the clinic.