Volume 27, Number 4 Table of Contents Articles Outsourcing and Contract Manufacturing in the Pharmaceutical Industry by Magdalena Nannei, Sandra Rumiano This article reviews the considerations involved to decide whether...
Volume 27, Number 3 Table of Contents Articles Testing by Roy F. Greenwald, Thys Smit This article describes the tremendous variability in requirements for testing and final acceptance of process skids and suggests...
Volume 27, Number 2 Table of Contents Articles Eight Steps to PAT: Using the Design for Lean Six Sigma Toll-Gate Process as Best Practice by Bikash Chatterjee, Jeremy Green This article outlines an eight-step six Sigma...
Volume 27, Number 1 Table of Contents Articles NIR spectrometry for the characterization of fuel components in a novel tamper-resistant pill bottle Choosing Technologies for Aseptic Filling: “Back to the Future by James...
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...