3D Tissue Models
Cell Based Assays
Claremont Resort
41 Tunnel Road
Berkeley, CA

Schedule of Presentations:

Tuesday, October 2, 2007
08:00:00 Conference Registration and Morning Coffee
08:45:00 Chairpersons' Welcome and Introduction Shalini Gupta
09:00:00 Quantitative Cell-Based Assays for Bioanalytical Use Shalini Gupta
09:30:00 Development of a Cell Growth Inhibition Assay for the Potency of A Monoclonal Antibody Product Assay Development Transfer and Validation Wei-Wei Zhang
10:15:00 30-Minute Morning Networking Break
10:45:00 Transfer of an Optimized Cell Based Cytotoxicity Assay to the Partner Company Assay Development Transfer and Validation Natalia Zhidkova
11:30:00 Development, Validation, & Transfer Strategies for Cell Based Assays Assay Development Transfer and Validation Xu-Rong Jiang, Renuka C Pillutla
12:15:00 Networking Luncheon
13:30:00 A New Approach Addressing Drug Interference on Cell Based NAb Assays Neutralizing Antibody Assays Yao Zhuang
14:15:00 Qualification of a Cell-Based Neutralization Assay for a Biopharmaceutical Product Neutralizing Antibody Assays Michele Fiscella
15:00:00 30-Minute Afternoon Networking Break
15:30:00 Validated Novel QPCR-Based Neutralizing Antibody Assay Neutralizing Antibody Assays Hicham Alaoui
16:00:00 Performance Evaluation of a Human Anti-PA IgG ELISA Using Samples from a Serum or Plasma Matrix Matrix Effect Jamie L Bird
16:30:00 How to Report Results from Functional Bioassays for Immunogenicity Matrix Effect | Panel Discussion Michele Fiscella, Darshana Jani, Hicham Alaoui
17:15:00 Conference Day One Concludes
Wednesday, October 3, 2007
08:00:00 Morning Coffee
08:30:00 Chairperson's Recap of Day One
08:45:00 Development, Transfer and Validation of a Cell-Based Toxin Neutralization Assay for Potency Testing of Anthrax Immune Globulin Intravenous (Human), 10% (AIGIV) Potency Assessment John G Collard
08:45:00 A Complement Dependent Cytotoxicity (CDC) Assay as a Potency Release Assay for a Monoclonal Antibody Drug Product (mAb-Z): Application of Inactivated mAb-Z in Assay Development Potency Assessment John G Collard
10:15:00 30-Minute Refreshment & Networking Break
10:45:00 Development of a real time PCR-based potency bioassay for human interferon-beta Potency Assessment Larisa O Miller
11:30:00 Overview of Commercial Off The Shelf Statistical Software Packages Potency Assessment Martin Kane
12:15:00 Networking Luncheon
13:15:00 Multiplexing Assays as Both Potency and Cell Based Assays Potency Assessment Pankaj Oberoi
13:45:00 Development, Validation, & Transfer of a Rapid Homogeneous Quantitative Apoptosis-Bioassay for Determing Biological Potency of Anti-TNF Therapy Potency Assessment Xu-Rong Jiang
14:15:00 New Technologies Applied to Cell Based Assay Development Potency Assessment Pankaj Oberoi, Jamie L Bird
15:00:00 Conference Concludes
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