4th Annual Cell Based Assays 
Main Conference Day One
Tuesday, October 7, 2008
| 8:30 | Conference Registration & Morning Coffee |
| 9:30 | Quantitative Cell Based Assays for Bioanalytical Use Cell based bioactivity assays that measure the biological activity of drug or any other analyte of interest in serum samples also hold a lot of promise in answering some important questions during drug development. - Shalini Gupta, PhD, Director, Medical Sciences, AMGEN |
| 10:15 | 30-Morning Networking Break |
| 10:45 | A Sensitive and Robust Western Blot Cell Based Assay to Measure the Activity of Botulinum Neurotoxin Serotype A Cell based assays are critically important for measurements of BoNT/A activity in field and biological samples, in-process samples, and formulated products, to reduce the need for in vivo testing of toxin activity, and to identify inhibitors of BoNT/A action. A well-designed cell based assay should be able to evaluate, indirectly or directly, all three steps in BoNT activity: receptor binding, internalization and translocation, and catalytic activity. Methods: A new 96-well plate cell based assay has been developed using differentiated Neuro-2a cells and a Western Blot read-out with an Allergan custom antibody to SNAP25197 that specifically recognizes the cleaved product of BoNT/A. Accuracy, precision, parallelism, specificity, and robustness of the assay were evaluated. Results: The assay is based on a 7 point dose-response curve fitted with a four parameter logistic model that generated EC50 values of 3.5 nM on average. The assay is routinely run by five operators with Z’ values greater than 0.5 and signal-to-noise values greater than 10 fold. Further optimization of differentiation, BoNT/A treatment, and Western blot conditions resulted in increased sensitivity and EC50 values of 50 to 100 pM. Conclusion: A new specific and robust mediumthroughput screening Western Blot cell based assay for measuring BoNT/A activity has been developed and characterized. Optimization of the assay resulted in increased sensitivity that at the moment is still insufficient for developing a potency assay for product release, but may be useful for evaluation of more concentrated samples. - Joanne Wang, Senior Professional, ALLERGAN |
| 11:30 | Case Study on the Development and Qualification of a Cell Based Neutralization Assay for an Anti-Toxin Antibody Neutralizing antibody assay development, cell based assay, qualification and drug interference. A case study of the development, optimization and qualification of a cell based neutralization assay for an anti-toxin monoclonal antibody. Topics to be covered include:
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| 12:15 | Networking Luncheon |
| 1:30 | Specific Strategies to Overcome Your Cell Based Assay Challenges
- Shalini Gupta, PhD, Director, Medical Sciences, AMGEN Panelists: Stephen Ullrich, Senior Scientist, HUMAN GENOME SCIENCES Ester Fernandez-Salas, PhD, Principal Scientist, Neurotoxin Research Program, ALLERGAN |
| 2:15 | Transfer of Cell Based Assays: Don’t Assume Too Much Logistics
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| 3:00 | 30-Minute Afternoon Networking Break |
| 3:30 | Floating Assay Cut Point Approach to Determining NAb Positivity in Immunogenicity Testing Significant variations between individual donor matrixes could make a statistically derived assay cut point not obtainable. A floating assay cut point approach provides a solution by leveraging on detecting the difference resulted from the presence of NAbs in an individualized way that is less influenced by matrix variation among the donor population. The benefits and limitations of this approach will be discussed with some example. - Yao Zhuang, PhD, Senior Scientist, AMGEN |
| 4:15 | Development, Validation, & Transfer Strategies for Cell Based Assays Assay Development
- Yao Zhuang, PhD, Senior Scientist, AMGEN |
| 5:00 | End of Day One |
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