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Considerations for a Decentralized Manufacturing Paradigm

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POD is suitable for a wide range of products, including oral solid dosage forms, mAbs, and cell therapy. 2 October 2019. Duplication enables rapid scale-up and scale-out, new facilities can be constructed in less than 12 months, and isolated operation avoids cross-contamination. BioPharm International. iSpeak blog. link] 33 Adiga, R.,

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Regulatory Landscape for Raw Materials: CMC Considerations

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During the pandemic, the pharmaceutical industry faced challenges in the production of COVID-19 therapeutics and vaccines to meet global demand, as well as mitigation of drug shortages for non-COVID-19-related products, without compromising product quality or patient safety. Published November 2019. 9 Lo Surdo, J. Cauchon, C.