October 20, 2011
The 2011 American Association of Pharmaceutical Scientists (AAPS) Annual Meeting and Exposition is being held in Washington, D.C. from October 23rd-27th. Scientists from all over the world will be gathering to meet, learn about and promote breakthrough research and technologies.
On Oct 24th, Virginia Litwin, Ph.D., Principal Scientist at Covance Central Laboratory will be making a presentation, "Applying the Fit-for-Purpose Validation Approach to Flow Cytometric Methods." Dr. Litwin is an invited speaker at a special symposium on the 5th Anniversary of the Fit-for-Purpose Method Validation Approach. The special symposium will emphasize practical applications of fit-for-purpose biomarker assay development and validation, including application of validation principles of endogenous biomarker assays, where they have provided unique assay value, and where they have revealed potential limitations resulting in recommendations to better apply these approaches. Dr. Litwin's abstract is below.
Flow cytometry allows for the simultaneous measurement of multiple cellular components both on the cell surface and within intracellular compartments. It is also amenable to the measurement of soluble analytes such as cytokines, drug compound, or anti-drug antibodies in solution. This flexible, powerful technology can be applied to all stages the drug development process -- from target discovery and characterization, to the evaluation of clinical responses. Compared to other methodologies commonly used in drug development such as plate-based immunoassays and mass spectrometry, flow cytometric methods can be more complex to develop and validate. The increasing variety of sample types, reagents, instrumentation, and software analysis programs combined with a lack of reference material to demonstrate accuracy of measurements, contribute to unique validation challenges. This presentation will discuss the application of “Fit-for-Purpose” method validation approach to flow cytometric assays.