Process Chromatography: A Guide to Validation by Gail K. Sofer,L. E. E. Nystrom

By Gail K. Sofer,L. E. E. Nystrom

learn and improvement into organic items for healing use has elevated dramatically over the past 10 years. With this, strict regulatory standards were imposed by means of gurus resembling the U.S. nutrition & Drug management, in order that this day validation has turn into a key factor within the biopharmaceutical industry.
This concise publication addresses validation matters within the chromatography of biotherapeutics. It covers technique layout, qualification and validation, together with an outline of analytical ideas commonplace within the validation of procedures. A concluding part reviews on product changeover and provides 4 case studies.

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