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 to avoid common pitfalls. For the uninitiated, separate chapters also deal with basic ...
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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 to avoid common pitfalls. For the uninitiated, separate chapters also deal with basic chromatography theory and properties of biological molecules. 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.
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