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

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.

Key Features
* Considers the entire scope of process chromatography, including scale up, regulatory issues, equipment, evaluation studies, scheduling, and cost-effectiveness
* Provides examples from companies with established processes and approved biotherapeutics
* Includes an appendix which lists the most pertinent regulatory documents, allowing the user to gather necessary information to comply with global regulatory expectations for process chromatography
* Contains a modeling program on the included disk

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.