Biopharmaceutical Process Validation (Biotechnology and Bioprocessing)

✍ Scribed by Gail Sofer

Publisher: Informa Healthcare
Year: 2000
Tongue: English
Leaves: 402
Series: Biotechnology and Bioprocessing Series
Edition: 1
Category: Library

No coin nor oath required. For personal study only.

✦ Synopsis

Enables biopharmaceutical developers and producers to ensure safe products, reduce risk of adverse reactions in patients, and avoid recalls by outlining sophisticated validation approaches to characterizing processes, process intermediates, and final products, emphasizing cost effectiveness while determining what levels of validation are required for different phases of development, license application, and process improvements. Sofer is director of regulatory services at BioReliance. Zabriskie is director of biopharmaceutical process sciences at Biogen.

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