
ISPE Conference on Manufacturing Excellence
25-28 February 2008
Hyatt Regency Tampa
Tampa, Florida, U.S.
Biotechnology Facility Delivery: From Concept to License
Does your company really know what it risks when developing a new large scale biotechnology facility, or when expanding an existing one?
This seminar helps you develop a top to bottom mitigation plan with guidance from industry professionals with front line experience. Learn from those who built facilities and had to correct equipment failures, downtime, scratched batches, and reduced efficiency when “going big” backfired. You should walk away with a solid understanding of the risks your company may face and an assessment of whether your facility will realize efficiency levels and the cost savings anticipated by “going big.”
There will be discussion at the end of every presentation. Presentations include:
- How to build or expand to a successful world scale biotechnology facility
- How engineering, procurement, validation, and commissioning integrates with construction management
- The technical, fabrication and construction issues faced by large facilities
- Equipment scale for best cost
- Technical challenges with multiple large scale bioreactors,
- Technical challenges for production retention while an expansion is brought on stream
Industry trends will emerge from presentations as well as from participant input, providing an excellent opportunity for generating best practices and innovative ideas from which all can benefit.
How You Will Benefit
At the conclusion of this session, participants will be able to:
- Understand some of the issues associated with large scale biotechnology projects
- Explain technical and operational challenges with large scale facilities
- Recognize industry trends
- Explain the limitations that the industry faces particularly as it relates to equipment, construction, and start up
Who Should Attend
Equipment, project and design engineers, project managers, plant managers, operations and maintenance engineers, equipment suppliers and plant designers
Communities of Practice (COPs)
Biotechnology, Process/Product Development, and Project Management
Related Technical Documents
Available from ISPE - www.ISPE.org/publications
Biopharmaceutical Manufacturing Facilities Baseline® Guide
Seminar Leader
- C.R. Green, Director, Design Engineering, Fluor Daniel
Speakers
- Lars Boettcher, Head of Eng'g Filtration Sys, Sartorius BBI Systems GmbH
- Carla Boragno, Sr Director of Project Eng'g, Genentech
- Evelyn Gayer, Regional Sales Manager, Paul Mueller Co
- Gerald Geisler, Director Global Engineering, Bristol-Myers Squibb
- Cary Kapper, Product Manager, Paul Mueller Co
- Hans Koning-Bastiaan, CCP2 Project Director, Genentech Inc
- Venkatesh Natarajan, Consulting Engineer, Bioprocess Division, MilliporeCorporation
- Kim Nelson, PhD, Director Biopharm Services, CRB Consulting Engineers, Inc.

