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Development and Manufacture of a Cell Culture Process for a Phase 1 Biopharmaceutical Product /
Biopharmaceutical products, which make up a growing class of drug products, are manufactured through a series of bioprocessing operations. Using a hypothetical biopharmaceutical product as a model, this case study covers basic technical concepts in upstream bioprocess operations as well as the regul...
| Cote: | Libro Electrónico |
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| Auteur principal: | |
| Format: | Électronique eBook |
| Langue: | Inglés |
| Publié: |
New York, N.Y. :
McGraw-Hill Education,
2020.
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| Collection: | McGraw-Hill's AccessEngineering.
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| Sujets: | |
| Accès en ligne: | Texto completo |
| Résumé: | Biopharmaceutical products, which make up a growing class of drug products, are manufactured through a series of bioprocessing operations. Using a hypothetical biopharmaceutical product as a model, this case study covers basic technical concepts in upstream bioprocess operations as well as the regulatory requirements for Phase 1 clinical trials, Investigational New Drug applications, and Current Good Manufacturing Practices. |
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| Description matérielle: | 1 online resource : illustrations. Also issued in print and PDF version. |
| Bibliographie: | Includes bibliographical references and index. |