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CMC Analytical Comparability Masterclass

Participants will be introduced to state-of-the art analytical methods and concepts. This will include topics such as analytical characterization of biosimilar and reference product, quality target product profile, acceptable range of variability, and justification of differences. Case studies of originator biologics and biosimilar products incl. examples addressing the development of biosimilar monoclonal antibody products will be discussed.

Date: 7.9.2013 - 18.9.2013
Location: Vienna, Austria


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