Wow! eBook
Handbook of Process Chromatography: Development, Manufacturing, Validation and Economics 2nd Edition
Author(s): Gunter Jagschies (Author), Gail K. Sofer (Author), Lars Hagel (Author)
- Publisher: Academic Press
- Publication Date: December 22, 2007
- Edition: 2nd
- Language: English
- Print length: 382 pages
- ISBN-10: 9780123740236
- ISBN-13: 0123740231
Book Description
Updates include:
– sources and productivity
– types of products made today
– experiences in clinical and licensed products
– economics
– current status of validation
– illustrations and tables
– automated column packing
– automated systems
New topics include:
– the use of disposables
– multiproduct versus dedicated production
– design principles for chromatography media and filters
– ultrafiltration principles and optimization
– risk assessments
– characterization studies
– design space
– platform technologies
– process analytical technologies (PATs)
– biogenerics
– comparability assessments
Key Features:
– new approaches to process optimiaztion
– use of patform technologies
– applying risk assessment to process design
Editorial Reviews
About the Author
Gail Sofer has been consulting with biotechnology and pharmaceutical companies for the past five years through the Fast Trak Validation(r) group of PharmaciaBiotech as the Director of International Validation Development. A series of publications on validation have provided guidance to many in this arena. She is active in organizations such as PDA and ASTM.
Lars Hagel is a Ph.D. in analytical chemistry and also Associate Professor at the University of Uppsala. Dr. Hagel has held different management positions within the R&D department and is now a senior scientific consultant of Pharmacia Biotech. He is a member of the board for The Swedish Centre for Bioseparations, and he chairs the Centre for Bioprocess Technology. Dr. Hagel’s research has focused upon practical implications of chromatography theory and he has published a vast number of papers and chapters, with special reference to gel filtration.
