Table of Contents

Articles

Using Technology Transfer to Maximize Business Efficiency
by Russ Somma, PhD
This article presents a technology transfer approach that can help prevent costly delays, leverage the ability to change, and speed time to market.
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Technology Transfer as a Strategic Tool: Bridging the Valley of Death
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.
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Small-Scale Bioreactor Platform for Bioprocess Optimization
by Marisha Ben-Tchavtchavadze, Michel Perrier, and Mario Jolicoeur
This article was developed from the winning student poster presentation at the 2006 ISPE Annual Meeting.
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Industry Interview Series: Dr. Emilio Emini, Executive Vice President of Vaccine Research and Development, Wyeth Pharmaceuticals
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.
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Global Tracking System: Case Study in Risk-Based Validation
by Philip Rees, Marcel Boere, Frans van Oosten, and Giorgio Civaroli
This article discusses how the risk assessment method was applied to the validation effort of a pilot global tracking system.
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Use and Misuse of Capital Cost Estimate Contingency – Why Deleting it Makes Projects More Expensive, Not Less
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.
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Dynamic Simulation in Pharmaceutical Operations
by Joseph S. Fox and Dustin Teschke
This article highlights dynamic simulation as a tool for improving capital utilization and Overall Equipment Efficiency (OEE).
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ISPE Baseline® Pharmaceutical Engineering Guide for New and Renovated Facilities Volume 6: Biopharmaceutical Manufacturing Facilities – Executive Summary
This executive summary provides an overview of the ISPE Baseline® Guide; Biopharmaceutical Manufacturing Facilities, which applies to products and facilities that house biotechnological processes.
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