The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

Each year for the past three years, there have been about 50 new molecular medicines approved by the United States Food & Drug Administration (FDA), of which approximately 25% were new biopharmaceuticals. Over 200 recombinant proteins, monoclonal antibodies, antibody drug conjugates, fusion prot...

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Autor principal: Geigert, John (Autor)
Autor Corporativo: SpringerLink (Online service)
Formato: Electrónico eBook
Lenguaje:inglés
Publicado: Cham : Springer Nature Switzerland : Imprint: Springer, 2023.
Edición:4th ed. 2023.
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Acceso en línea:https://doi.org/10.1007/978-3-031-31909-9
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