Process Validation in Manufacturing of Biopharmaceuticals
Guidelines, Current Practices, and Industrial Case Studies
1st Edition
Published on 24. March 2000
Book
Hardback
402 pages
978-0-8247-0249-6 (ISBN)
Description
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.
More details
Language
English
Place of publication
New York
United States
Publishing group
Taylor & Francis Inc
Target group
College/higher education
Professional and scholarly
Dimensions
Height: 229 mm
Width: 152 mm
Weight
635 gr
ISBN-13
978-0-8247-0249-6 (9780824702496)
Copyright in bibliographic data is held by Nielsen Book Services Limited or its licensors: all rights reserved.
Schweitzer Classification
Other editions
New editions
Gail Sofer
Process Validation in Manufacturing of Biopharmaceuticals
Guidelines, Current Practices, and Industrial Case Studies
Book
03/2005
2nd Edition
Informa Healthcare
€193.50
Article not available
Person
Content
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.