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...
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...
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...
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