Validation of Biopharmaceutical Manufacturing Processes (ACS Symposium Series)
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Product Description
The first complete one-volume reference on the topic, this book describes all aspects of process validation in the licensure of recombinant biologics, for both protein and non-protein products. It covers product synthesis, purification, and filling/finishing.
Product Details
- Amazon Sales Rank: #856913 in Books
- Published on: 1998-08-27
- Original language: English
- Number of items: 1
- Binding: Hardcover
- 191 pages
Editorial Reviews
Review
"A collection of 12 papers presented at an April 1997 symposium held in San Francisco, California, detailing components of a process validation package. Papers address all aspects of biopharmaceutical manufacturing processes, including cell culture and fermentation, product purification, and fill-finish operations. Specific topics include process characterization studies to facilitate validation of a recombinant protein fermentation, validation of continuously perfused cell culture processes for production of monoclonal antibodies, and impact on the development and validation of the manufacturing process for well-characterized products."--SciTech Book News
