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The Challenge of CMC Regulatory Compliance for Biopharmaceuticals John Geigert Fourth Edition 2023 edition
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The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
John Geigert
In summary, this book: Updates real-world CMC deficiency examples with current examples; Addresses current FDA and EMA requirements and expectations for CMC regulatory compliance; Now includes CMC regulatory compliance for the new gene-based biopharmaceuticals.
573 pages, 1 Illustrations, black and white; XXXV, 573 p. 1 illus.
| Media | Books Paperback Book (Book with soft cover and glued back) |
| Released | June 16, 2024 |
| ISBN13 | 9783031319112 |
| Publishers | Springer International Publishing AG |
| Pages | 573 |
| Dimensions | 150 × 220 × 10 mm · 914 g |
| Language | German |