Transfer of Methods Supporting Biologics and Vaccines
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*Timothy Schofield, Merck Research Labs 

Keywords: Method transfer, biologics, equivalence testing

Transfer of analytical methods supporting biologics and vaccines is complicated by complex and highly variable biological systems. Many of these assays may be linked to clinical performance, and thus subject to specifications that have been established from materials that were tested in the development laboratory. Thus transfer must account for the risk that the method characteristics have changed, and may generate results for commercial lots that either earmark a satisfactory lot as failing, or an unsatisfactory lot as passing specification. Transfer study strategies have been proposed based on method parameters or on tolerance intervals. This presentation will describe a framework for establishing the equivalence between two laboratories with emphasis on the associated risks, and compare and contrast the parametric and tolerance approaches.