Research Catalog

Title

• PAT applied in biopharmaceutical process development and manufacturing : an enabling tool for quality-by-design / edited by Cenk Undey... [et al.].

Publication

Boca Raton, FL : CRC Press, c2012.

Items in the Library & Off-site

Details

Additional Authors

Undey, Cenk

Description

xxvii, 299 p. : ill.; 25 cm.

Summary

"This book summarizes the state of the art in process analytical technologies applied to various aspects of biopharmaceutical process development and manufacturing. The text summarizes regulatory perspectives, FDA/EMEA guidelines, and new expectations. In addition, it explores new technology, especially in the area of real-time monitoring for end-point control as well as new sensor and analytical technologies. It details established and emerging measurement technologies, including future needs and challenges that require further research. The authors also present successful industrial-scale deployment case studies and strategies from the biopharmaceutical industry and discuss future trends"--

Series Statement

• Biotechnology and bioprocessing series ; v. 33

Uniform Title

Biotechnology and bioprocessing series 33.

Subject

• Biopharmaceutics
• Biopharmaceutics > methods
• Drug Compounding
• Drug development
• MEDICAL / Pharmacology
• Pharmaceutical Preparations
• Pharmaceutical biotechnology
• SCIENCE / Biotechnology
• SCIENCE / Chemistry / Analytic
• Technology, Pharmaceutical > standards

Bibliography (note)

• Includes bibliographical references and index.

Processing Action (note)

• committed to retain

Contents

Scientific and regulatory overview of process analytical technology in bioprocesses / Rakhi B. Shah [and others] -- Strategic vision for integrated process analytical technology and advanced control in biologics manufacturing / Melissa M. St. Amand [and others] -- Multivariate techniques in biopharmaceutical process development / Jeremy S. Conner -- Analysis, monitoring, control, and optimization of batch processes: multivariate dynamic data modeling / Theodora Kourti -- Multivariate data analysis in biopharmaceuticals / Joydeep Ganguly [and others] -- Process analytical technology advances and applications in recombinant protein cell culture processes / Ana Veronica Carvalhal, Victor M. Saucedo -- Process analytical technology applied to raw materials / Erik Skibsted -- Process analysis technology for enhanced verification of bioprocess system cleaning / Peter K Walter [and others] -- Cell culture process analytical technology multiplexing near-infrared / Mariana L. Fazenda, Linda M. Harvey, Brian McNeil -- Process analytical technology for bioseparation unit operations / Anurag S. Rathore, Vishal Ghare, Rahul Bhambure -- Process analytical technology use in biofuels manufacturing / Pedro Felizardo, Jose C. Menezes, M. Joana Neiva-Correia -- Application of microreactors for innovative bioprocess development and manufacturing / Seth T. Rodgers, A. Peter Russo -- Real-time monitoring and controlling of lyophilization process parameters through process analytical technology tools -- Feroz Jameel, William J. Kessler -- Process analytical technology's role in operational excellence / Fetanet Ceylan Erzen, Manbir Sodhi -- Conclusions, current status, and future vision process analytical technology in biologics / Duncan Low, Ray Chrisman.

ISBN

9781439829455 (hardback : acid-free paper)

LCCN

^^2011031862

OCLC

746489188

Owning Institutions

Harvard Library