PAT Applied in Biopharmaceutical Process Development And Manufacturing: An Enabling Tool for Quality-by-Design

Cenk Undey, Duncan Low, Jose C. Menezes, Mel Koch

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December 7, 2011 by CRC Press
Reference - 327 Pages - 125 B/W Illustrations
ISBN 9781439829455 - CAT# K11448
Series: Biotechnology and Bioprocessing

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Features

  • Evaluates all data flowing from the bioprocess to facilitate manufacturing excellence and lean manufacturing concepts
  • Uses multivariate data analysis (MVDA) for problem solving and model development at the pilot scale, demonstrating how this knowledge can flow into uses for production control
  • Offers many examples of the ways in which design teams are using PAT to not only speed process development for biopharmaceutical production, but also how it is being used to insure high-quality production with enhanced regulatory compliance
  • Designed for students and others beginning efforts in PAT for QbD purposes

Summary

As with all of pharmaceutical production, the regulatory environment for the production of therapeutics has been changing as a direct result of the US FDA-initiated Quality by Design (QbD) guidelines and corresponding activities of the International Committee for Harmonization (ICH). Given the rapid growth in the biopharmaceutical area and the complexity of the molecules, the optimum use of which are still being developed, there is a great need for flexible and proactive teams in order to satisfy the regulatory requirements during process development.

Process Analytical Technologies (PAT) applied in biopharmaceutical process development and manufacturing have received significant attention in recent years as an enabler to the QbD paradigm. PAT Applied in Biopharmaceutical Process Development and Manufacturing covers technological advances in measurement sciences, data acquisition, monitoring, and control. Technical leaders present real-life case studies in areas including measuring and monitoring raw materials, cell culture, purification, and cleaning and lyophilization processes via advanced PAT. They also explore how data are collected and analyzed using advanced analytical techniques such as multivariate data analysis, monitoring, and control in real-time.

Invaluable for experienced practitioners in PAT in biopharmaceuticals, this book is an excellent reference guide for regulatory officials and a vital training aid for students who need to learn the state of the art in this interdisciplinary and exciting area.