Course - King of Prussia, PA, United States
The course begins with basic development, highlighting technical requirements, regulatory requirements and industry trends. We start by detailing how to select and maintain critical reagents, then move to assay formats. This includes understanding physical processes behind the four parameter model and how to interpret curve shape in terms of assay optimization. Then we move into qualification and validation of the assays to support pre-clinical and clinical studies. Part 1 of this course ends with preparation of the assay for use in a bioanalytical laboratory, including validation, establishing robustness, determining acceptable and practical system suitability criteria and suggestions for long term maintenance of the assay.
Part 2 of this course starts with an overview of immunology followed by the requirements of an immunogenicity program, including the establishment of a tiered testing approach for screening, confirmation assay analysis, titer assays and neutralizing antibody assays
(Courtesy of Validating Cell Based Assays for NAb Detection, via ppdi.com)
Thu, Aug 01, 2013 - Fri, Aug 02, 2013
Doubletree Hotel by Hilton, Philadelphia/Valley Forge
301 West Dekalb Pike, King of Prussia, PA 19406, United States
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