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By L. Oestreich, K. Auchincloss, and M. Giaquinto, Greenleaf Health | 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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By Ionna Deni, contract market researcher, BioPlan Associates | In 2023, biomanufacturers showed an increasing interest in continuous manufacturing, but uptake, believe it or not, slowed down. Let’s explore the reasons why with data from BioPlan Associates. |
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By P. Mains, PMP, T. Zacharatos, and A. McFarland, MSc, ValSource | 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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| Revolution In The EU Pharmaceutical Legislation Ahead | White Paper | By Adam Tuszyner, Mabion | Discover how this revised legislation, which will supersede existing regulations that fostered the availability of safe and effective medicines for the past two decades, is set to impact the industry. |
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| Early Product Characterization De-Risks Biologics Development | White Paper | By Daniel Galbraith, Ph.D., MilliporeSigma | The relationship between physicochemical profile and biological activity — and how this affects clinical performance — is key to informed decisions, accelerated development, and risk reduction. |
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