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Model based design of a biochemical cultivation process

✍ Scribed by V. Galvanauskas; R. Simutis; N. Volk; A. Lübbert

Publisher: Springer
Year: 1998
Tongue: English
Weight: 273 KB
Volume: 18
Category: Article
ISSN: 1615-7605
DOI: 10.1007/s004490050435

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## Abstract A licensed pharmaceutical process is required to be executed within the validated ranges throughout the lifetime of product manufacturing. Changes to the process, especially for processes involving biological products, usually require the manufacturer to demonstrate that the safety and