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| Navigate The Regulatory Space To Biosimilar Approval | Article | Cytiva | The biosimilar patent cliff is reshaping pharma, creating unprecedented opportunities for biotech and CDMOs. Explore expert regulatory support that can help you navigate this shift with confidence. |
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By Kyle Winn and Adam Walker, W2 Cleanroom Consulting | Contamination control gaps arise when two dynamics merge — when processes become familiar and workloads increase. Here's how to spot them before they spin out of control. | |
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By Erin Hartmann and Liz Oestreich, ELIQUENT Life Sciences | The FDA issued a total of 303 warning letters to drug and biologics products in Fiscal Year 2025 (FY25), an increase from FY24. This article reveals key agency focal points and trends. | |
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By BioPhorum | Establishing a robust single-use systems (SUS) interchangeability program can be a pivotal feature of a supply chain resiliency initiative. Review this framework to find your optimal single-use components. | |
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