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The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

Autor*innen

John Geigert

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4,8(4)Abgeben

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456 Seiten
16 Lesestunden

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Focusing on the complexities of biopharmaceutical development, this book offers practical guidance for Chemistry, Manufacturing & Control (CMC) teams navigating regulatory compliance. It emphasizes the importance of integrating CMC strategy early in the clinical study planning process, addressing challenges posed by advanced products like biosimilars and genetically engineered therapies. The updated edition also highlights the impact of expedited clinical pathways on compliance timelines, making it a vital resource for professionals in pharmaceutical development, manufacturing, and regulatory affairs.