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Use of Integrated Modules for Bioassay Analysis IMBA  Form

Use of Integrated Modules for Bioassay Analysis IMBA Form

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hello this is dr. Steven Feldman professor of dermatology at the Wake Forest Baptist Medical Center in winston-salem North Carolina I'll be discussing the publication acceptable changes in quality attributes of glycosylated biopharmaceuticals by Martin she's balloon colleagues this study report was published in Nature Biotechnology I selected this article because it provides more transparency anchoring the debate about acceptable changes in quality attributes data reveal physical chemical differences in each of the glycosylated recombinant therapeutic proteins in this study this article highlights several different factors that may account for changes in quality attributes manufacturers are required to demonstrate the process change does not alter the clinical safety or efficacy of a biologic product based on principles of the comparability exercise regulated and guidelines well let's look at the methods first three major marketing's like constellated bi

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