Handbook of Process Chromatography: A Guide to Optimization, Scale Up, and Validation
| Author | : | |
| Rating | : | 4.69 (812 Votes) |
| Asin | : | 012654266X |
| Format Type | : | paperback |
| Number of Pages | : | 387 Pages |
| Publish Date | : | 2014-08-11 |
| Language | : | English |
DESCRIPTION:
The aim is to help the reader to realize the scope of issues that must be evaluated and avoid common pitfalls. From the Back Cover 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. 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 th
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. They also cover properties of biological molecules, and reveal pitfalls often encountered in the process. 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 wi
"Validation Review" according to William D Hatton. Perfect for someone wanting to learn about IQ/OQ/PQ for chromatography. Easy to read. Good presentation. Useful examples. Software is great addition. Very practical approach. Plenty of useful up-to-date references. Great buy!
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. Dr. 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 Unive