Education Sessions
Platform Approaches to Streamline Development (306)
| 29 October 12.45-15.45 | Track: Manufacturing Operations |
ISPE CEUs: 0.2
(PDF Current as of 9 October 2008)
The pharmaceutical and biotechnology industry have a lot to learn from other industries in which platform strategies have been applied with great success. With increasing pressures for cost-savings, efficiency, and speed to market, platform strategies will continue to develop in our pharmaceutical industry. This session provides the opportunity to compare actual case studies and participate in a forum for sharing best practices.
How You Will Benefit
At the end of this session, participants will be able to:
- Apply lessons learned from experienced users of platform technologies
- Identify the possible functions that can benefit from platform/standard strategies
- Recognize the pitfalls of implementation in order to perform a proper benefit analysis
- Understand the limitations of platform approaches
Technical Documents - www.ISPE.org/publications
Biopharmaceutical Manufacturing Facilities Baseline® Guide, and Oral Solid Dosage Forms Baseline® Guide
Who Should Attend
Development and manufacturing scientists, engineers, and managers
ISPE Communities of Practice (COPs)
Active Pharmaceutical Ingredients (API), Biotechnology (Biotech), Product Process Development (PPD)
Proposed Agenda
- Use of process platforms
- Use of equipment platforms
- Use of analytical platforms
- Standardization of other development activities
Session Leader
- Michiel Ultee, Vice President, Process Sciences, Laureate Pharma, Inc., USA
Session Speakers
- Jie Chen, Associate Director of Process Technologies, Dyax, USA
- Robert Steininger, Sr Vice President, Mfg, Acceleron Pharma, USA
- Peter Watler, Principal Consultant, Hyde Engineering + Consulting Inc, USA