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| Mabion Capacity Update July 2024: Large Molecule Development | Explore our new installations in upstream development, new bioreactors, as well as downstream development and fill-finish. This state of the art EU-GMP certified facility is staffed by a team of 250 professionals, and capacity is now available. |
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By Eric Marshall, Partnership for DSCSA Governance | The FDA recently announced it would exempt small dispensers from requirements of the Drug Supply Chain Security Act (DSCSA) until Nov. 27, 2026. The industry has made tremendous progress so far with DSCSA, but this discretion will make compliance more challenging. |
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| Transport And Storage Of Antibody Drug Conjugates | Article | By Brian Moloney, Single Use Support | Explore the benefits of single-use technologies to enhance safety, streamline your operations, and elevate your biopharmaceutical processes as they relate to ADCs. |
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| New Container Protects Bulk Frozen Biopharmaceuticals | Q&A | W.L. Gore & Associates | Learn more about a flexible freeze container that maintains package integrity after freezing at -86 °C. (-123 °F) through its durable design, minimizing product loss due to package failure. |
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| Embracing Biotech Chaos With Memo's Erik van den Berg | Erik van den Berg is CEO and board member at Memo Therapeutics, and he's a student of biotech chaos. In fact, he's been embracing it with intention for the past 30 years. On the Business of Biotech, he walks us through the management of that chaos in specific detail. We cover it all, with van den Berg offering detailed insight into the guiding principles of navigating constant change in biotech. |
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By Jayet Moon and Arun Mathew | The FDA released a new draft guidance, "Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products," in July. The public comment period closes on Sept. 9, 2024. |
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FOCUS ON [FILL-FINISH - INDUSTRY INSIGHTS] |
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