Volume 25, Number 2
by Jeff Odum
This article focuses on the implementation of closed process systems, controlled processing capabilities, and manufacturing flexibility.
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.
by Allan MacDonald
This article discusses some of the challenges, execution methods, and potential opportunities of Design Qualification (DQ).
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.
by Thom Hallock
This article presents the advantages and opportunities of relocating or a biotechnology company in the Southeastern United States.
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.
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.
A timeline of the history of ISPE through the last 25 years of service to the pharmaceutical industry.
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.)