Process Chromatography: A Guide to Validation

by G.K. Sofer and L. E.E. Nystrom

Research and development into biological products for therapeutic use has increased dramatically over the last 10 years. With this, strict regulatory requirements have been imposed by authorities such as the U.S. Food & Drug Administration, so that today validation has become a key issue in the biopharmaceutical industry.This concise book addresses validation issues in the chromatography of biotherapeutics. It covers process design, qualification...

• Format: Hardcover
• Language: English
• ISBN: 0126542678
• ISBN13: 9780126542677
• Release Date: November 1991
• Publisher: Academic Press
• Length: 96 Pages
• Weight: 0.65 lbs.
• Dimensions: 0.5" x 6.9" x 9.9"