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By Kieran Falvey, Pharmalliance Consulting Ltd. | This article addresses the three contamination control challenges that are specific to the CDMO environment, provides five practical steps any organization can act on now, and more. | |
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A conversation between the EMA's Brendan Cuddy and Life Science Connect's Jon O'Connell | EMA’s Brendan Cuddy explains how regulators are adapting oversight to global supply chains, new technologies, and growing operational complexity. | |
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By Juergen Metzger, Pharma-Technology-Consulting LLC | In many aseptic fill/finish projects, the factory acceptance test (FAT) has become the first true integration test of the entire project. That is a problem. Here's how to flip that mindset. | |
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By Natasha Kehimkar, Malida Advisors | Friction often comes from unspoken expectations. Before production begins, treat the combined sponsor-CDMO group as one extended team and intentionally make “how we work together” visible. | |
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