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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| Formato: | Electrónico eBook |
| Lenguaje: | inglés |
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Cham :
Springer Nature Switzerland : Imprint: Springer,
2023.
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| 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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