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 processing capabilities, and manufacturing flexibility.

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.

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).

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.

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.

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.

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.

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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