| Day OneDecember 10, 2007 |
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| 08:00 |
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EVENT REGISTRATION & COFFEE |
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| 09:00 |
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CHAIRPERSON'S OPENING REMARKS |
Laura Bush,
Editor in Chief,
Biopharm International
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| 09:05 |
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FUTURE DIRECTIONS IN MONOCLONAL ANTIBODY DEVELOPMENT & PRODUCTION |
- Latest technologies in generating effective antibody leads
- Latest developments to achieve speed-to-clinic cell lines and processes
- Methods of ensuring success of commercial antibody production processes
- Regulatory implications and considerations to support cell line and process changes
Dr. Kevin Bailey,
Vice President, Process Develo,
Regeneron Pharmaceuticals
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| 09:40 |
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INTEGRATED PROCESS DEVELOPMENT: EFFICIENTLY BALANCING UPSTREAM & DOWNSTREAM |
- Reducing batch processing time and improving facility output through simple non-Protein A purification processes
- Optimizing conditions to remove process related contaminants on ion exchange resin vs. affinity chromatography
Dr. Alahari Arunakumari,
Senior Director, Process Devel,
Medarex
USA
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| 10:15 |
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| 10:40 |
| INTERACTIVE WORKSHOP |
| STRATEGIES TO PURIFY MONOCLONAL ANTIBODIES WITH CERAMIC HYDROXYAPATITE |
- Science behind the separation power of CHT
- Use for purification of monocloncal antibodies
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Dr. Mark Snyder,
Manager, Process R&D Applicati,
Bio-Rad Laboratories
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| INTERACTIVE WORKSHOP |
| DISPOSABLES IN ACTION |
- Disposable solutions: A combination of products, applications support and services
- Regulatory requirements and validation data
- Case study - Pharmaceutical Company in Europe with Product X.
Edward Graham-Brown,
Vice President Strategic Marke,
Millipore
Johan Westman,
VP Advanced Manufacturing Solu,
Millipore
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| 11:15 |
| Maintaining successful relationships with external manufacturing facilities during expansion efforts |
Dr. Adam Sabouni,
Vice President, Global Pharmac,
Stiefel Laboratories
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| CURRENT ISSUES IN FERMENTATION |
| Optimizing cell culture methods |
Modernizing vaccine production through utilizing the cell-based platform
Allan Taggart,
Vice President, Government Pro,
MedImmune
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| 11:50 |
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Innovative tools and technologies to achieve process excellence |
- High volume biomanufacturing constraints: Quality, Compliance and Technology
- The rationale behind process excellence: continuous improvement and process consistency
- Examples of achieving process excellence using multivariate modelling, PAT, and computational fluid dynamics
Dr. Sourav Kundu,
Director, Manufacturing Scien,
Amgen
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| 12:25 |
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IMPLEMENTING DISPOSABLE TECHNOLOGY TO BIOMANUFACTURING
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- Overcoming key challenges during implementation efforts
- Evaluating the future of disposable bioreactors
- Understanding the cGMP and regulatory perspectives
Dr. Sadettin Ozturk,
Head, Bioprocess Technology,
Centocor Biologics
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| 13:00 |
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| 14:00 |
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Enhancing bioprocessing methods through novel techniques |
Case study: boosting productivity through effective antibody cell line development
- Isolation, characterization and production of cross-neutralizing Human monoclonal antibodies against SARS and Henipa Viruses
Dr. Zhongyu Zhu,
Scientist,
SAIC Frederick NCI
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| 14:40 |
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| 18:00 |
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UPGRADING PROCESS DEVELOPMENT TECHNIQUES: MAINTAINING COMPLIANCE AND QUALITY STANDARDS |
Efficiently scaling up processes to improve reliability
- Scaling up therapeutic protein and monoclonal antibody drug substance processes
- Achieving efficient technology transfer when scaling up processes
- Identifying critical parameters in process characterization and validation
- Understanding key features in robust process design
Dr. Maninder Hora,
Vice President Process Develop,
PDL Biopharma
USA
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| 18:35 |
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NETWORKING DRINKS RECEPTION |
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