Handbook of Process Chromatography: A Guide to Optimization, Scale Up, and Validation - Hardcover

Sofer, Gail K.; Hagel, Lars

Hardcover

ISBN 10: 012654266X ISBN 13: 9780126542660

Verlag: Academic Press, 1997

Inhaltsangabe

This handbook is an excellent reference for graduates and researchers in biotechnology and practitioners in the pharmaceutical industry who wish to develop a commercial chromatographic purification process. The authors guide readers through each step of the development process, beginning with basic chromatography theory and practice and incorporating examples from companies with established processes and approved biotherapeutics. They also cover properties of biological molecules, and reveal pitfalls often encountered in the process. Design strategies are discussed in depth, considering common starting materials and their impact on purification design, scale-up concerns, and validation. The authors use their extensive consulting and teaching experience to present a practical approach to developing an optimal chromatographic process, scaling it up, and meeting requirements set forth by regulatory agencies. The included diskette contains modeling exercises providing valuable insights into the influence of chromatographic parameters on separation results and the impact of process design on production costs, making the Handbook an excellent hands-on teaching tool.

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Über die Autorinnen und Autoren

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.

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This Handbook offers a practical approach to developing an optimal chromatographic process, scaling it up, and adapting it to comply with requirements set by world-wide regulatory agencies.

The reader is led through every stage of the development process using examples from companies with established processes and approved biotherapeutics. The aim is to help the reader to realize the scope of issues that must be evaluated and avoid common pitfalls. For the uninitiated, separate chapters also deal with basic chromatography theory and properties of biological molecules.

The authors have used their extensive experience in teaching and consultancy to present a practical approach to the critical issue of validation. They have also compiled an appendix of the most pertinent regulatory documents. The accompanying disk contains modeling exercises providing valuable insight into the influence of chromatographic parameters on the separation result and the impact of process design on production costs.

The holistic and practical approach of the Handbook make it an essential reference for graduates and researchers in biochemical engineering and biotechnology as well as practitioners in the pharmaceutical industry. The enclosed disk also makes the Handbook an excellent hands-on teaching tool.

Details zur Ausgabe

• Verlag: Academic Press
• Erscheinungsdatum: 1997
• Sprache: Englisch
• ISBN 10: 012654266X
• ISBN 13: 9780126542660
• Einband: Gebundene Ausgabe
• Anzahl der Seiten: 387
• Kontakt zum Hersteller: Nicht verfügbar
• Verantwortliche Person: eVatmaster Consulting GmbH; 497000000000; contact@evatmaster.com; ; Bettinastr. 30,60325; Frankfurt am Main; 60325; Deutschland