Volume 27, Number 5
by Russ Somma
This article presents a technology transfer approach that can help prevent costly delays, leverage the ability to change, and speed time to market.
by Jeff Odum
This article was developed from the presentation “Technology Transfer: Implementing Current Best Practice Guidelines to Manage Risk” presented at the ISPE Conference in Paris, 2007.
by Marisha Ben-Tchavtchavadze, Michel Perrier, Mario Jolicoeur
This article was developed from the winning student poster presentation at the 2006 ISPE Annual Meeting.
A well-known and accomplished vaccine research leader discusses the state of vaccine research today, the challenges ahead, and how Wyeth continues to play a significant role in vaccine research and development.
by Philip Rees, Marcel Boere, Frans van Oosten, Giorgio Civaroli
This article discusses how the risk assessment method was applied to the validation effort of a pilot global tracking system.
by Gordon R. Lawrence
This article presents the general principles of what contingency and estimate accuracy are in order to remove common misconceptions about their composition and use.
by Joseph S. Fox, Dustin Teschke
This article highlights dynamic simulation as a tool for improving capital utilization and Overall Equipment Efficiency (OEE).
This executive summary provides an overview of the ISPE Baseline® Guide; Biopharmaceutical Manufacturing Facilities, which applies to products and facilities that house biotechnological processes.
NOTE: Pharmaceutical Engineering article PDF documents are not to be posted on any Web site, blog site or page, or any other internet site without prior permission from ISPE. (Copyright © ISPE. All rights reserved.)