ISPE Conference on Manufacturing Excellence
25-28 February 2008
Hyatt Regency Tampa
Tampa, Florida, U.S.
Lyophilization: Meeting the Challenges of a Critical Technology
| 27-28 February 1.2 CEUs |
|
Lyophilization (freeze drying) of parenteral products is perhaps the most challenging unit operation within a manufacturing chain’s strive toward excellence in product delivery. The exceptional product attributes of a lyophilized product need to be balanced with the challenges which many times limit the utilization of this technology:
- Complex formulation and lyophilization cycle development
- High cost and complexity of equipment
- Extremely long process times requiring multiple units in order to balance a manufacturing line
Why freeze dry? Lyophilization is advantageous when a drug product is both unstable in solution and heat labile but requires quick, complete rehydration for administration. The principal benefits of Lyophilization are:
- Minimum loss of activity for heat labile drug substances
- Quick complete rehydration
- Accurate, particulate free dosing in final product containers
This intensive two-day seminar will provide a comprehensive look at several of the major process as well as equipment issues in state of the art lyophilization practice. Best practices in lyophilization equipment selection, operation and maintenance will also be a feature. A special workshop will focus on Hot Topics to be generated by registrant submissions of issues and challenges faced in lyophilization practice today.
How You Will Benefit
At the conclusion of this session, participants will be able to:
- Understand lyophilization process fundamentals
- Understand the scientific approach for lyophilized product formulation development and why lyophilization may be a good choice
- Gain insight on cycle development and scale-up issues
- Examine container and closure issues
- Become familiar with major lyophilizer equipment subsystems
- Discuss a PAT approach to in-line control of the lyophilization process
- Learn about the challenges associated with manual and automatic load/unload systems
Who Should Attend
Design, development, operations, maintenance and compliance professionals involved in lyophilization of drug products
Communities of Practice (COPs)
Biotechnology, Process/Product Development, and Sterile Products Processing
Related Technical Documents
Available from ISPE - www.ISPE.org/publications
Biopharmaceutical Manufacturing Facilities
Baseline® Guide, Sterile Manufacturing Facilities Baseline Guide
Seminar Leaders
- Miquel Galan, Director of Innovation + R & D, TELSTAR LYO
- Reuben Zielinski, Senior Director Operations, Catalent Pharma Solutions
Speakers
- Karen Bossert, PhD,RPh, VP, Scientific Affairs, Lyophilization Technology Inc
- Joseph Brendle, Product Manager, WL Gore & Associates Inc
- Patrick Cook, Process Engineer, Eli Lilly and Co
- Kieran Crowley, Zydis Formulation Manager, Catalent Pharma Solutions
- David Doleski, Biologist, CBER / FDA
- Paul Gold, Director, Drug Product Equipment Technology, Pfizer
- Philippe Le Gall, Director, Sales & Marketing, BioCORP
- Michael Molloy, Principal, Qualification Process Solutions
- Stephanie Passot, PhD, Assistant Professor, AgroParis Tech
- Ernesto Renzi, Vice President, BOC Edwards Pharma Systems