- BioPharm International-05-01-2002
- Volume 15
- Issue 5
Validation of Large-Scale Chromatographic Processes, Part 1: Case Study of Neuleze Capture on Macroprep High-S
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.
Articles in this issue
over 23 years ago
Info+over 23 years ago
Analytical Advances: Strategies in Clarifying Mammalian Culturesover 23 years ago
Analytical Advances: Using Image Informatics - Focusing Proteomicsover 23 years ago
The Not-So-Sure Thingover 23 years ago
Washington Report: Vaccine Shortages put Spotlight on Productionover 23 years ago
Guest Editorial: Validation Bingoover 23 years ago
Travel Notes: Yes, Virginia, There is Biotech in the CommonwealthNewsletter
Stay at the forefront of biopharmaceutical innovation—subscribe to BioPharm International for expert insights on drug development, manufacturing, compliance, and more.