Loading…
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...
| Call Number: | Libro Electrónico |
|---|---|
| Main Author: | |
| Format: | Electronic eBook |
| Language: | Inglés |
| Published: |
New York, N.Y. :
McGraw-Hill Education,
2020.
|
| Series: | McGraw-Hill's AccessEngineering.
|
| Subjects: | |
| Online Access: | Texto completo |
| Summary: | 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. |
|---|---|
| Physical Description: | 1 online resource : illustrations. Also issued in print and PDF version. |
| Bibliography: | Includes bibliographical references and index. |