Validation of Large-Scale Chromatographic Processes, Part 1: Case Study of Neuleze Capture on Macroprep High-S

Timothy N. Breece;Charles Schmelzer;

Publication

Article

May 15, 2002

BioPharm International

BioPharm International-05-01-2002

Volume15

Issue 5

Validation of Large-Scale Chromatographic Processes, Part 1: Case Study of Neuleze Capture on Macroprep High-S

Author(s):

Timothy N. Breece,Charles Schmelzer

by Timothy N. Breece, and Charles Schmelzer, Genentech, Inc. FDA requires chromatography procedures to be validated for reuse, cleanability, sanitization, robustness, and (potentially) for virus removal. This case study follows the development of a validation process that combines reuse and characterization studies, defines acceptable running parameters, reduces costs, and meets GMP requirements.

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The Not-So-Sure Thing

Washington Report: Vaccine Shortages put Spotlight on Production

Outsourcing Outlook: E-Procurement ? Successfully Using and Managing Reverse Auctions

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Validation of Large-Scale Chromatographic Processes, Part 1: Case Study of Neuleze Capture on Macroprep High-S

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