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USP Chapter <1032>, Design and Development of Bioassay provides a framework for bioassay development, though many of the statistical concepts are not implemented from lack of understanding. This talk will cover the use of different statistical designs and analysis for developing a bioassay that is robust.
A comprehensive suite of highly sensitive and complementary binding and reporter gene assays have been implemented to assess the potency of a kλ-Body as part of product quality analysis and characterization studies. Results obtained using the different assays were correlated to demonstrate the assays stability indicating properties, locate degradations and initiate the identification of critical quality attributes.
N-Glycosylation of biotherapeutics is an important critical quality attribute. Glycans can influence protein stability, serum clearance, immunogenicity and pharmacokinetics. Therefore it is crucial to monitor the full glycan profile of a glycoprotein throughout discovery, clinical and manufacturing phases. A High-throughput RapifluorMS N-glycan method has been employed in our lab to address the challenges that are encountered with product quality support and meet aggressive timelines. This presentation will provide an overview of the development workflow to automate all the steps from sample preparation to data analysis of the RapifluorMS released N-glycan analysis.