Editorial
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Getting To Know MAM, The New Quality Control Strategy On the Block
3/11/2024
When characterizing PQAs, the multi-attribute method offers a one-stop shop for analysis. This article explores technical considerations for this emerging strategy.
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Navigating China's Biologics Approval And Accelerated Pathways
3/8/2024
Pharma companies doing business in China have four key routes to register drugs faster than the standard ways. This discussion breaks down accelerated pathways and offers tips on how to approach them.
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Shocking! Biotech Facilities Don't Maintain Themselves
3/4/2024
Don't get trapped in the misconception that only core process systems need maintenance. Here are some real-life examples of facility maintenance programs gone wrong.
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Green Gains In Biopharma Without Closing Facilities?
2/29/2024
Going green is virtually impossible for biopharma companies with legacy systems, but going greener might be within reach. Here are some ideas to get started.
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How Pharma 4.0 Can Unlock The Full Potential Of External Manufacturing
2/27/2024
To address today's challenges and other headwinds, pharma/biotech organizations and CMO/CDMO partners need to re-evaluate and improve externalized operating models. Consider further investing in digitalizing collaboration processes as part of operational excellence and digital transformation road map efforts.
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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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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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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.