BPI Analytical and Quality Summit 
Event Information
Document Title
Agenda-at-a-Glance
| Agenda-at-a-Glance | |||
| Monday, June 2, 2008 | Exhibit/Poster Hall Hours: 3:15 pm - 6:45 pm | ||
| Pre-Conference Workshops | |||
| Morning | Workshop A: The Principles and Application of Design of Experiments (DOE) in Bioprocessing - A Hands-On Course | Workshop B: Oligomerization and High Molecular Weight Species Determination - Understanding and Meeting Current Regulatory Requirements | Workshop C: Best Practices for Working with Contract Organizations for Analytical Support |
| Method Validation | Biophysical Analysis | Process Characterization | |
| Main Conference | |||
| Afternoon | Keynote Presentation: Interdependence of Product Characterization, Analytical Method Validation, and Comparability Assessment Chulani Karunatilake, Ph.D., Amgen, Inc. | Keynote Presentation: New Methods for Characterization of Protein Aggregation Tudor Arvinte, Ph.D., University of Geneva, Switzerland | Keynote Presentation: Quality by Design in Biotechnology: Why and How? Gail Burnett, Ph.D., Genentech, Inc. |
| The Validation Lifecycle - Phase-Appropriate Methods and Planning | Problem Solving Using Biophysical Analysis | Automation and Platforming of Process Development and Control | |
| 4:45 pm | Technology Workshops | ||
| 5:15 pm | Exhibit and Poster Viewing | ||
| Tuesday, June 3, 2008 | Exhibit/Poster Hall Hours: 10:00 am - 3:45 pm | ||
| Morning | Keynote Presentation: Applying Quality by Design Principles to Assay Development and Validation Dieter Schmalzing, Ph.D., Genentech, Inc. | Keynote Presentation: The Application of Novel Biophysical Methods for Drug Development Jun Liu, Ph.D., Genentech, Inc. | Keynote Presentation: Application of QbD for Development and Manufacturing of a BioPharamaceutical Rohin Mhatre, Ph.D., Biogen Idec, Inc. |
| Problem-Solving Case Studies | Characterization of High Concentration Protein Products | Process Characterization and Control Recovery and Purification | |
| New Regulatory Requirements for Method Validation | Computational Characterization | Process Characterization and Control Formulation and Fill/Finish | |
| 11:45 am | Technology Workshops | ||
| 12:15 pm | Networking Luncheon, Exhibit and Poster Viewing | ||
| Afternoon | Bioassay Development and Validation | Biophysical Analysis in Formulation Development | Process Characterization and Control Cell Culture and Fermentation |
| Analytical Method Transfers | Evaluating the Stability of Macromolecules | Data Management | |
| Wednesday, June 4, 2008 | |||
| Morning | Case Studies of Advanced Analytical Methods | Developing Design Space and Control Space | |
| Characterization of Complex Biologics | Case Studies of Process Characterization and Control | ||
| By selecting from among more than 70 speaker presentations, you can customize your conference experience to meet the needs of you and your organization. And, you will receive a CD-ROM containing program materials for all three meetings, an invaluable resource for the future. | |||
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