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 comp

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Yes, you can access PAT Applied in Biopharmaceutical Process Development And Manufacturing by Cenk Undey,Duncan Low,Jose C. Menezes,Mel Koch in PDF and/or ePUB format, as well as other popular books in Medicine & Biotechnology. We have over one million books available in our catalogue for you to explore.

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Cover
Half Title
Title
Copyright
Table of Contents
Forword
Introduction
Contributors
Chapter 1 Scientific and Regulatory Overview of Process Analytical Technology in Bioprocesses
Chapter 2 Strategic Vision for Integrated Process Analytical Technology and Advanced Control in Biologics Manufacturing
Chapter 3 Multivariate Techniques in Biopharmaceutical Process
Chapter 4 Analysis, Monitoring, Control, and Optimization of Batch Processes: Multivariate Dynamic Data Modeling
Chapter 5 Multivariate Data Analysis in Biopharmaceuticals
Chapter 6 Process Analytical Technology Advances and Applications in Recombinant Protein Cell Culture Processes
Chapter 7 Process Analytical Technology Applied to Raw Materials
Chapter 8 Process Analysis Technology for Enhanced Verification of Bioprocess System Cleaning .
Chapter 9 Cell Culture Process Analytical Technology Multiplexing Near- Infrared
Chapter 10 Process Analytical Technology for Bioseparation Unit Operations
Chapter 11 Process Analytical Technology Use in Biofuels Manufacturing
Chapter 12 Application of Microreactors for Innovative Bioprocess Development and Manufacturing
Chapter 13 Real-Time Monitoring and Controlling of Lyophilization Process Parameters through Process Analytical Technology Tools
Chapter 14 Process Analytical Technology’s Role in Operational Excellence
Chapter 15 Conclusions, Current Status, and Future Vision of Process Analytical Technology in Biologics

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Table of contents