Process Development

Providing an interactive forum where process development scientists can meet and discuss current issues.

Leadership

CO-CHAIRS
Thomas Harrington, Lonza Hopkinton, Inc.
Gerry Nicklas, Acambis, Inc.
Robert Shaw, Millipore Corporation

Mission

The mission of the Process Development Committee is to provide: an interactive forum where process development scientists can meet and discuss current issues faced in process development, educational speakers from industry and government agencies, a forum for biotechnology professionals involved in drug development to network.

Action Plan

The Committee will act to provide speakers and topics of interest to member companies. The forum is intended to foster and facilitate communication and open discussion of topics, issues and ideas of interest to Process Development Scientists and anyone interested in this key area of drug development.

Topics

Scale-up, scale-down strategies for process development.
The issues associated with out-sourcing development.
Development data needs through various stages of clinical trials.
The importance of identifying key process control parameters early in development.
CGMP as related to drug development.

Meetings

Date	Event
4/30/08	Alternative Strategies for Process Characterization Designs: Balancing Risks, Costs and Benefits

Past Presentations

Date	Presentation
3/26/08 12:00pm	Analytical Methods Utilized Throughout Process Development, Product Characterization and Formulation Screening: Matches Made in heaven or Shotgun Weddings? by Hersh Mehta, Ph.D. Senior Director, Acambis, USA/UK

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