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

Timothy N. Breece

,
Charles Schmelzer

BioPharm International, BioPharm International-05-01-2002, Volume 15, Issue 5

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.