Process Validation in Manufacturing of Biopharmaceuticals: Guidelines, Current Practices, and Industrial Case Studies - Rilegato

Sofer, Gail

Rilegato

ISBN 10: 0824702492 ISBN 13: 9780824702496

Casa editrice: CRC Press, 2000

Riassunto

A study of biopharmaceutical process validation. It aims to enable developers and producers to ensure safe products, reduce the risk of adverse reactions in patients, and avoid recalls by outlining sophisticated validation approaches to characterize processes, process intermediates, and final product fully. The text emphasizes cost effectiveness while determining what level of validation is required for different phases of development, license application, and process improvements.

Su questo libro

Contenuti

Regulatory trends related to process validation; a biotech validation concept; establishing process robustness using designed experiments; identification and establishment of operating ranges of critical process variables; cell line characterization; process validation and characterization; recovery operations; purification issues; validation of the purification process for virus clearance evaluation; chromatography media lifetime; validation of filtration; cleaning -multiuse facility issues; role of analytical testing in biopharmaceutical analysis; process validation in biopharmaceutical manufacturing; regulatory reform for biotechnology-derived products - the regulatory impact of process changes on validation; special issues for synthetic antisense oligonucleotides; special issues for DNA vaccines; process development and process validation for plasmid DNA vaccines; ex vivo autologous cell therapies.

Dettagli dell'edizione

• Editore: CRC Press
• Data di pubblicazione: 2000
• Lingua: Inglese
• ISBN 10: 0824702492
• ISBN 13: 9780824702496
• Rilegatura: Copertina rigida
• Numero edizione: 1
• Numero di pagine: 402
• Contatto del produttore: non disponibile
• Persona responsabile: non disponibile