Volume 26, Number 6 Table of Contents Articles Quality by Design, Validation, and PAT: Operational, Statistical, and Engineering Perspectives by Ron Branning, Lynn Torbeck, Cliff Campbell This article demonstrates how...
Volume 26, Number 5 Table of Contents Articles Biotech CIP Cycle Development: Case Study Examples Utilizing QRM by Matt Wiencek This article presents case study examples of CIP cycle development activities and lessons...
Volume 26, Number 4 Table of Contents Articles A Holistic Analysis of Pharmaceutical Manufacturing and Distribution: Are Conventional Supply Chain Techniques Appropriate? by Christopher J. Savage, Kevin J. Roberts, Xue Z...
Volume 26, Number 3 Table of Contents Articles Primer of Design and Construction Delivery Methods for Today’s Modern Pharmaceutical and Biotech Facilities by Brian Sirbovan, Dave DiProspero, Brian Larson This article...
Volume 26, Number 2 Table of Contents Articles Large-Scale Chromatography Becoming State-of-the-Art by Roy Greenwald, Bill Rochelle This article describes the process, design, and fabrication considerations to take into...
Volume 26, Number 1 Table of Contents Articles Process Analytical Technology (PAT) and Scalable Automation for Bioprocess Control and Monitoring – A Case Study by John Nichols, Stuart Preston, Joydeep Ganguly, Gerrit...
Volume 25, Number 6 Table of Contents Articles Process Modeling Proposition in Biopharmaceutical Manufacturing by Sei Murakami, Peter Watler, Takashi Ishihara, Shuichi Yamamoto This article describes advancements in...
Volume 25, Number 5 Table of Contents Articles Applying Six Sigma Principles to a Bulk and Fill/Finish Biopharmaceutical Process by Bikash Chatterjee, Benir Ruano, Kenneth Myers This article discusses the methods and...
Volume 25, Number 4 Table of Contents Articles A Practical Guide to Construction by Wael Allan, Andrew D. Skibo This article focuses on construction contractors who can deliver qualified facilities and presents the...
Volume 25, Number 3 Table of Contents Articles Implementing PAT Step by Step as a Process Optimization Tool by Connie Langberg Heinzeand Jan Ruud Hansen This article provides a straightforward step by step approach for...
Volume 25, Number 2 Table of Contents Articles Trends in Biopharmaceutical Manufacturing Facility Design: What’s Hot! by Jeff Odum This article focuses on the implementation of closed process systems, controlled...
Volume 25, Number 1 Table of Contents Articles Automated Release of Water Using On-Line TOC Analysis and FDA Risk-Based cGMP, Inspection, and PAT Principles by Richard Godec, Nissan Cohen This article illustrates the...
Volume 24, Number 6 Table of Contents Articles A New Suite of Automated Bioreactors at Genentech: A Case Study Employing Standards by Ronald E. Men This case study reports on one effort to design and automate a suite of...
Volume 24, Number 5 Table of Contents Articles Measuring Process Temperature in Small Diameter Lines by Greg Thorp, John Zwak This article presents the advantages and disadvantages of various temperature measurement...
Volume 24, Number 4 Table of Contents Articles A Practical Approach to Commissioning and Qualification - A Symbiotic Relationship by Timothy D Blackburn This article offers a practical approach to commissioning and a...
Volume 24, Number 3 Table of Contents Articles Country Profile: Poland - May/June 2004 by Poland Affiliate This section takes a look at the pharmaceutical industry in Poland; produced in collaboration with ISPE Poland...
Volume 24, Number 2 Table of Contents Articles Cleaning of a Tablet Packaging Machine Validated by a Contractor - A Case Study by Heidi Meinertz Jensen This case study describes a validation assignment carried out by a...
Volume 24, Number 1 Table of Contents Articles API Chemical Synthesis Trends in Reactor Heat Transfer Design by Stephen Hall, Andy Stoker This article explores basic and advanced concepts, presents some calculations, and...