Overview

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.

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9780841235670

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Reviews

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<br>

"""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"

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