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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| Main Author: |
Geigert, J. 1948- |
| Other Authors: |
SpringerLink (Online service) |
| Format: |
eBook
|
| Language: |
English
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| Published: |
Cham :
Springer,
[2023]
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| Physical Description: |
1 online resource (xxxv, 573 pages)
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| Edition: |
Fourth edition. |
| Subjects: |
|