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Event Information
Conference: September 20 - 24, 2010 · Exhibition: September 21-23, 2010 ·
Document Title
Agenda Overview
Agenda Overview
- To view agenda details: Click the underlined links within the glance below (where applicable) to view the detailed agenda for that track or symposium.
- To view the complete agenda: Please download the PDF brochure.
Monday, September 20, 2010 | ||||
| 1:00 pm - 5:00 pm | Symposium #1: Prevention of Microbial and Viral Contamination of Mammalian Cell Culture Processes - Lessons Learned and Case Studies | Symposium #2: How Much Data is Enough? The Statistical Approach to Process Validation | Symposium #3: Technology Transfer for Biopharmaceuticals | |
Tuesday, September 21, 2010 | ||||||
| Managing Manufacturing Networks | Product Lifecycle Management | Hydroxyapatite for Biomanufacturing | Strategic Discussion Forum | Formulation Strategies for Protein Therapeutics | ||
| Morning | Leveraging our Assets - How do We Reconcile the Installed Base with Current Technologies and Demand? | Process Design: Establishing Design Space and Robust Process Parameters | Advancements and Case Studies of Hydroxyapatite for Biomanufacturing - Sponsored Session by Bio-Rad |
Pre-Conference Workshop: The Formulator of the Future: Using High Throughput Technologies, Informatics and Rational Design to Accelerate and Optimize Formulation Development |
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| Networking Refreshment Break | ||||||
| Leveraging our Assets - How do We Reconcile the Installed Base with Current Technologies and Demand? (session continues) | Process Design: Establishing Design Space and Robust Process Parameters (session continues) | Advancements and Case Studies of Hydroxyapatite for Biomanufacturing (session continues) | Managing Partners and Contractors - Practical Solutions to the Issues that Arise | |||
| 11:45 am | Technology Workshops Sponsored by: Sheffield Bio-Science, Mirus Bio and Novasep | |||||
| 12:15 pm | Luncheon Presentation Sponsored by: Millipore Corporation | |||||
| Afternoon | Smart Flexibility in Facilities | Implementation and Execution | Manufacturing: What will Take us to the Next Level of Efficiency and Economics? Sponsored by Pall Life Sciences | Keynote Presentations: Holistic QbD; Particles, Particles Everywhere | ||
| Development of Formulation and Drug Product Design Space | ||||||
| Comparability and Characterization Exercises during Formulation Development | ||||||
| Networking Refreshment Break | ||||||
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Opening Keynote Presentations: I. Regulatory Modernization - FDA's Desired State for Product Quality II. The Role of Biosimilars in Driving Innovation in the Biopharmaceutical Industry |
Comparability and Characterization Exercises during Formulation Development (session continues) | |||||
| Technology Workshop | ||||||
| 5:30 pm | Opening Night Reception Sponsored by Pall Life Sciences in the Exhibit and Poster Hall | |||||
Wednesday, September 22, 2010 | ||||||||
| Managing Manufacturing Networks | Product Lifecycle Management | Raw Materials / Supply Chain | Strategic Discussion Forum | Recovery & Purification | Rapid Vaccine Development and Production | Formulation Strategies for Protein Therapeutics | ||
| 7:15 am | Technology Workshop with Continental Breakfast Sponsored by: SAFC Biosciences | Keynote Presentation: Global Vaccine Production Challenges: Emerging Immuno-therapeutics, Manufacturing Flexibility and Reducing COGS | Keynote Presentation: Modeling Protein Degradation Processes and the Development of Rational Approaches to Stabilization | |||||
| Morning | The Future of Manufacturing Networks and Facilities | Continuous Process Improvement | Point Counterpoint Session: Integrating Raw Materials and Suppliers into a Pharmaceutical Quality System | Advances in Process Monitoring and Control in Downstream Processing | ||||
| Lessons Learned from the 2009 Flu Season to Guide Rapid Vaccine Development and Manufacturing Scale Up | Keynote Presentation: NIST Perspective on Standards and GMP Processes for Subvisible Particles in Protein Therapeutics | |||||||
| Networking Refreshment Break Sponsored by Luminex in Exhibit and Poster Hall | ||||||||
| The Future of Manufacturing Networks and Facilities (session continues) | Continuous Process Improvement (session continues) | Point Counterpoint Session: Integrating Raw Materials and Suppliers into a Pharmaceutical Quality System (session continues) | Continuous Disposable Multi-Column Chroma-tography: Emerging Technology to Enable More Efficient Downstream Processing - Sponsored by Tarpon Biosystems | Cell Culture & Upstream Processing | Process Development for Novel Vaccines and Immuno-therapeutics | Implementing Analytical Methods and Control Steps for Subvisible Particles | ||
| Integrating In-Line Process Monitoring and Control Technologies in Upstream Processing | ||||||||
| 12:00 pm | Technology Workshops Sponsored by: Diosynth Biotechnology, GE Healthcare, Natrix Separations Inc., and New Brunswick Scientific | Defending Biosimilar Competition: Bioprocess IP Protections for Next Generation Vaccines and Immuno-therapeutics | Technology Workshop | |||||
| 12:30 pm | Networking Luncheon in Exhibit and Poster Hall with Dedicated Poster Viewing | |||||||
| Afternoon | Plenary Session - Critical Industry Issues | Process Development and Analytical Characterization for Vaccine Production | Evaluation and Control of Bio-pharmaceutical Stability | |||||
| Networking Refreshment Break Sponsored by Luminex in Exhibit and Poster Hall | ||||||||
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Keynote Presentations: I. Sustainable Commercial Cell Culture Operations II. Finding a Home for Process and Product Development |
Process Development and Analytical Characterization for Vaccine Production (session continues) | Evaluation and Control of Bio-pharmaceutical Stability (session continues) | ||||||
| 5:30 pm | Networking Reception in Exhibit and Poster Hall Sponsored by BD Biosciences | |||||||
Thursday, September 23, 2010 | ||||||
| Recovery & Purification | Cell Culture & Upstream Processing | Emerging Analytical Requirements | Strategic Discussion Forum | Formulation Strategies for Protein Therapeutics | ||
| 7:15 am | Technology Workshop with Continental Breakfast Sponsored by: BD Biosciences | |||||
| Morning | Plenary Session - Integration of Upstream and Downstream Processing | Emerging Analytical Requirements and their Impact on Process Development and Manufacturing | Formulation Strategies for Vaccines | |||
| Networking Refreshment Break in Exhibit and Poster Hall | ||||||
| Breakthroughs to De-Bottleneck Downstream Processing | Accelerating & Optimizing Cell Line & Process Development | Emerging Analytical Requirements and their Impact on Process Development and Manufacturing (session continues) | Smart Flexibility: What Creates the Right Degree of Flexibility and Cost Reduction in Different Phases of Manufacturing | Formulation Impacts of Device and Packaging Systems | ||
| 12:00 pm | Technology Workshops Sponsored by: 3M Purification Inc., Irvine Scientific, Applied Biosystems, a part of Life Technologies, and Invitrogen, a part of Life Technologies | |||||
| 12:30 pm | Networking Luncheon in Exhibit and Poster Hall with Dedicated Poster Viewing | |||||
| 1:00 pm | Exhibit Hall Presentation: The Enduring Need for Operational Excellence: Lessons Learned from the Oil Field to Biotech and How Great Companies can Still Fall Short | |||||
| Afternoon | Implementing the Latest Tools and Techniques to Optimize the Harvest Step | Host Cell Engineering to Improve the Yield and Quality of Biotherapeutics | Development and Manufacturing Strategies for Biosimilars Products | Formulation Development for Next Generation Biologics | ||
| Networking Refreshment Break in Exhibit and Poster Hall (Last chance to consult with suppliers and view posters) | ||||||
| Overcoming Challenges of Production, Purification and Characterization of Next Generation Antibody-Like Molecules & Protein Therapeutics | Implementation of Novel Media Development and Feed Strategies | Site Tour to Amgen's BioNext Facility (space is limited) |
3:00 pm Conference Ends | |||
Friday, September 24, 2010 | |||
| Recovery & Purification | Cell Culture & Upstream Processing | ||
| Morning | Evaluation and Implementation of Next Generation Purification Technologies | What Comes Next after Titer Increase? | |
| Networking Refreshment Break | |||
| Process Characterization for Developing Design Space | Featured Presentation: An Industrial View of Biopharmaceutical Comparability and Characterization | ||
| Approaches to Improve Product Quality and Achieve Process Optimization | |||
| 12:15 pm | Technology Workshops Sponsored by: Novozymes Biopharma, Thermo Scientific and Rentschler Biotechnologie GmbH | ||
| 12:45 pm | Lunch on your own | ||
| Afternoon | Utilizing Continuous Processing to Decrease Operation Time and Improve Facility Utilization | Advantages of Using Mixed Mode Technologies | |
| Networking Refreshment Break | |||
| Applications of Automated, High-Throughput Technologies in Downstream Processing | Overcoming Challenges of Producing Specific Proteins | ||
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