Biopharmaceutical Process Validation (Biotechnology and...

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Biology and other natural sciences - Biotechnology
Biopharmaceutical Process Validation...

Biopharmaceutical Process Validation (Biotechnology and Bioprocessing)

Name: Biopharmaceutical Process Validation (Biotechnology and Bioprocessing)
ISBN: 9780824702496

Gail Sofer

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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.

Categories:

Biology and other natural sciences - Biotechnology

Year:

2000

Edition:

Publisher:

Informa Healthcare

Language:

english

Pages:

402

ISBN 10: