The Biotechnology and Bioprocessing series offers in-depth presentations from respected experts and thought leaders in academia and industry. Titles explore recent developments and best practices that facilitate successful commercialization of Biotech Products. The series focus is on technologies, process development improvements, and new applications that would result in production of safe and efficacious drugs utilizing robust, efficient and economical processes.
Biotransformations and Bioprocesses
PAT Applied in Biopharmaceutical Process Development And Manufacturing An Enabling Tool for Quality-by-Design
Process Synthesis for Fuel Ethanol Production
By Anurag Singh Rathore, Harold Baseman, Scott Rudge
December 18, 2023
The fourth edition of Process Validation in Manufacturing of Biopharmaceuticals is a practical and comprehensive resource illustrating the different approaches for successful validation of biopharmaceutical processes. A pivotal text in its field, this new edition provides guidelines and current ...
By Mukesh Doble, Anil Kumar Kruthiventi, Vilas Ganjanan Gaikar
October 17, 2019
From the laboratory to full-scale commercial production, this reference provides a clear and in-depth analysis of bioreactor design and operation and encompasses critical aspects of the biocatalytic manufacturing process. It clarifies principles in reaction and biochemical engineering, synthetic ...
By Nuala Calnan, Martin J Lipa, Paige E. Kane, Jose C. Menezes
June 16, 2017
This book addresses the rapidly emerging field of Knowledge Management in the pharmaceutical, medical devices and medical diagnostics industries. In particular, it explores the role that Knowledge Management can play in ensuring the delivery of safe and effective products to patients. The book also...
By Anurag Singh Rathore, Anurag S. Rathore, Gail Sofer
May 09, 2012
Process Validation in Manufacturing of Biopharmaceuticals, Third Edition delves into the key aspects and current practices of process validation. It includes discussion on the final version of the FDA 2011 Guidance for Industry on Process Validation Principles and Practices, commonly referred to as...
By Cenk Undey, Duncan Low, Jose C. Menezes, Mel Koch
December 07, 2011
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 ...
By C.A. Cardona, O.J. Sanchez, L.F. Gutierrez
December 03, 2009
Process engineering can potentially provide the means to develop economically viable and environmentally friendly technologies for the production of fuel ethanol. Focusing on a key tool of process engineering, Process Synthesis for Fuel Ethanol Production is a comprehensive guide to the design and ...
By Abhinav A. Shukla, Mark R. Etzel, Shishir Gadam
July 07, 2006
The biopharmaceutical industry has become an increasingly important player in the global economy, and the success of these products depends on the development and implementation of cost-effective, robust and scaleable production processes. Bioseparations-also called downstream processing- can be a ...
By Sadettin Ozturk, Wei-Shou Hu
August 30, 2005
Edited by two of the most distinguished pioneers in genetic manipulation and bioprocess technology, this bestselling reference presents a comprehensive overview of current cell culture technology used in the pharmaceutical industry. Contributions from several leading researchers showcase the ...
By B. Mattiasson
November 30, 1990
Contributors from European and US universities and corporations review recent developments in the integration of downstream processing and bioconversion, describing their experience with many separation technologies, including some still in the experimental stage. The topics include the construction...
By John Twork
May 25, 1990
This volume presents the reader with an overview of current chemical sensor technology and outlines a framework relating industrial bioprocess monitoring to modern process control technology. It deals with conventional multivariable control technology, focusing on bioprocess applications....