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I joined ISPE with the hope of giving something back to an industry that has served me well over the last 15 years. After attending one conference, I knew I wanted to become an active Member in the organisation. I wanted to have a role in ISPE activities and events that benefited other industry Members. I found the transition from attendee to active Member relatively easy. Despite the fact that ISPE is a society made up of volunteers, passion and professionalism in which business was conducted was eye opening. In my 10 years as a Member, I have made many friends who have afforded me the benefit of their experience within OUR industry and have changed both my professional and social view point. ISPE is a wonderful organisation and I hope to be part of it for years to come.

Nigel Frost, Managing Director
Thermal Transfer, Ltd., United Kingdom

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Pharmaceutical Engineering Archives

March/April 2005
Volume 25, Number 2

Theme: Biopharmaceuticals

 

 


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.
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Procedure for the Validation of Biological Active Pharmaceutical Ingredients (APIs) Manufacturing Processes
by Josée 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, PhD
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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Country Profile: Canada
by ISPE Canada Affiliate
This section takes a look at the pharmaceutical industry in Canada.
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ISPE Historical Timeline: 1980 - 2005
by ISPE
A timeline of the history of ISPE through the last 25 years of service to the pharmaceutical industry.
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