March/April 2005 Volume 25, Number 2



Trends in Biopharmaceutical Manufacturing Facility Design: What’s Hot!
by Jeff Odum
This article focuses on the implementation of closed process systems, controlled processing capabilities, and manufacturing flexibility.
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Procedure for the Validation of Biological Active Pharmaceutical Ingredients (APIs) Manufacturing Processes
by E Ethier
This article presents a procedure for the validation of biological API manufacturing processes. It details each step of the procedure for biological processes applications, and covers the regulatory requirements for biological APIs.
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Do You DQ? Design Qualification Challenges and Considerations
by Allan MacDonald
This article discusses some of the challenges, execution methods, and potential opportunities of Design Qualification (DQ).
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Interview with Florida Governor Jeb Bush
by Mark Mathis
Interview with Governor Jeb Bush conducted by Mark Mathis, Communications Chair of the ISPE Carolina-South Atlantic (CASA) Chapter, in November 2004.
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Biotech: A Wealth of Choices
by Thom Hallock
This article presents the advantages and opportunities of relocating or a biotechnology company in the Southeastern United States.
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Optimizing the Extended Clinical Supply Chain: Strategic Advantages for Clinical Trials
by Vikram Marla
This article presents an Extended Supply Chain System which encompasses all aspects of clinical supply information and provides study managers with a comprehensive picture of the supply flow.
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Pharmaceutical Drug Substance Due Diligence - A CMC Technical Assessment - Part 2
by Thomas J. DiFeo
This article provides a review of controls associated with the manufacturing process, process development and validation, elucidation of structure, control of the drug substance, container closure system, and stability. Part 1 of the article was published in March/April 2004.
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ISPE Historical Timeline: 1980 - 2005
A timeline of the history of ISPE through the last 25 years of service to the pharmaceutical industry.
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