Biotech COP Articles

Pharmaceutical Engineering Articles

Articles published in Pharmaceutical Engineering, ISPE’s bi-monthly member magazine that relate to the subject matter of the Biotech COP.

• Follow-on Biologics: Will the New Biologics Price Competition and Innovation Act Live Up to the Waxman-Hatch 1984 Expectations?
  March/April 2013, 33(2)
  by Michael R. Goodman
• Facility of the Future: Next Generation Manufacturing Forum Part I: “Why We Cannot Stay Here” – The Challenges, Risks, and Business Drivers for Changing the Paradigm
  January/February 2013, 33(1)
  by Mark F. Witcher, PhD, Ruben Carbonell, PhD, Jeff Odum, CPIP, Peter Bigelow, Patricia Lewis, and Michael Zivitz
• Biopharmaceutical Manufacturing in the Twenty-First Century – the Next Generation Manufacturing Facility
  March/April 2012, 32(2)
  by Mark F. Witcher, PhD and Jeff Odum CPIP
• Design and Optimization of a Large Scale Biopharmaceutical Facility Using Process Simulation and Scheduling Tools ( 5 MB)
  March/April 2010, 30(2)
  by Abdelaziz Toumi, Carmen Jungo, Mr. Victor Papavasileiou, Mr. Demetri Petrides, Christian Jürgens, Bernd Maier
• Biopharmaceutical Process Characterization: Defining the Design Space ( 273 KB)
  March/April 2008, 28(2)
  by Anthony Newcombe, Keith Watson, Claire Newcombe
• ISPE Baseline® Pharmaceutical Engineering Guide for New and Renovated Facilities Volume 6: Biopharmaceutical Manufacturing Facilities – Executive Summary ( 211 KB)
  September/October 2007, 27(5)
• Primer of Design and Construction Delivery Methods for Today’s Modern Pharmaceutical and Biotech Facilities ( 228 KB)
  May/June 2006, 26(3)
  by Brian Sirbovan, Dave DiProspero, Brian Larson
• Capital Costs for Biopharmaceutical Process Retrofit Projects ( 363 KB)
  May/June 2006), 26(3)
  by Stephen R. Higham
• Biotech CIP Cycle Development: Case Study Examples Utilizing QRM ( 197 KB)
  September/October 2006, 26(5)
  by Matt Wiencek
• The Role of Process Simulation in a Renovated Biologics Facility – A Case Study ( 486 KB)
  September/October 2006, 26(5)
  by Daniel Lavin, Himabindu Gopisetti, Peter N. Notwick
• Process Modeling Proposition in Biopharmaceutical Manufacturing ( 225 KB)
  November/December 2005, 25(6)
  by Sei Murakami, Peter Watler, Takashi Ishihara, Shuichi Yamamoto
• Project Scope Determination and Cost Control Using Technology Assessment Diagrams – A Biopharmaceutical ( 331 KB)
  November/December 2005, 25(6)
  by Mary Ellen Craft
• Biotech: A Wealth of Choices ( 92 KB)
  March/April 2005), 25(2)
  by Thom Hallock

Other Articles

• A Statistical Approach to Expanding Production Capacity
  BioProcess International, March 2013
  by Annette Kaya, Andrea Uebele, Anke Seeger, Hans ter Maat, David Estapé
• Developing an Integrated Continuous Bioprocessing Platform
  BioProcess International, December 2012
  by Maribel Rios
• Virus Safety of Biopharmaceuticals
  Contract Pharma, November 2011
  by Hazel Aranha, Ph.D.
• Challenging the Cleanroom Paradigm for Biopharmaceutical Manufacturing of Bulk Drug Substances
  BioPharm International, August 2011
  by Simon Chalk, Scott Probst, Paul Gil, Tim Palberg, Matt Kennedy, Joe Rogalewicz, Jeff Johnson, Ken Green

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