March / April 2011

March / April 2011 Cover

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Case Study: Genentech's ECP-1 Bacterial Manufacturing Facility, Overall Winner, 2010 Facility of the Year Awards
by Rochelle Runas
This article presents the story of how innovative project execution and strong teamwork overcame numerous challenges in the making of Genentech’s ECP-1 Bacterial Manufacturing Facility, Overall Winner of the 2010 Facility of the Year Awards.

Industry Interview Series: Timothy C. Tyson, Chairman and CEO, Aptuit, Inc.
Tim Tyson discusses how his career has evolved since his first interview with Pharmaceutical Engineering 18 years ago; his current role as Chairman and CEO of a Contract Research, Development, and Manufacturing Organization; and his work with the ILF’s Factory of the Future initiative. 

Alternative Methods for HEPA Filter Leak Detection
by Jim Meek, Dan Milholland, and Laszlo Litauszki, PhD
This article discusses HEPA filter leak detection methods that provide robust alternatives to current filter testing practices.

Single-Use Components for Flexible Biomanufacturing Processes
by Thorsten Peuker and Jean-Marc Cappia
This article presents the latest status of single-use technologies in biomanufacturing processes.

Optimizing the Design and Operation of Fill-Finish Facilities using Process Simulation and Scheduling Tools
by Demetri Petrides, Charles Siletti, José Jiménez, Petros Psathas, and Yvonne Mannion
This article presents examples and methodologies for optimizing the design and operation of fill-finish facilities using process simulation and scheduling tools.

Trends and Advances in Isolator Technology
by Volker Sigwarth and Thomas Huber
This article discusses the increasing use of isolator technology in modern aseptic processes and presents the latest developments and possibilities for this key equipment.

Standardizing Patient Safety Risk Management
by Mark Cupryk
This article presents the challenges in patient safety risk management for the Patient, US Food and Drug Administration (FDA), Healthcare Provider, and Sponsor. The article reviews specific risk management tools to show how audits can be leveraged by the Sponsor to provide additional patient safety focus and consistency across the medical product supply chain.

Business Process Management (BPM) Based Pharmaceutical Quality Management Systems: Win-Win Between Compliance and Competitiveness
by François Versini
This article shows how a BPM-based Quality Management System optimizes the way to comply with today’s evolving processes and stay competitive in the marketplace.