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Abstract:
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It is common for biopharmaceutical firms to utilize platform or “first-to-try” analytical methods and manufacturing processes in the development of new molecules such as monoclonal antibodies. As such, a rich repository of historical data from previously developed molecules may be available to inform the performance of these methods and processes. This presentation will explore the use of such platform knowledge via Bayesian methods in order to inform and enhance CMC development studies, particularly in the early-phase of a project where there is limited molecule-specific data available.
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