Charles Schmelzer

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Articles

Validation of Large-Scale Chromatographic Processes, Part 2: Results from the Case Study of Neuleze Capture on Macroprep High-S

Timothy N. Breece;Charles Schmelzer;Ellen Gilkerson

July 15th 2002

by Timothy N. Breece, Ellen Gilkerson, and Charles Schmelzer, Genentech, Inc.

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

Timothy N. Breece;Charles Schmelzer

May 15th 2002

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.