We develop analytical methods for protein biologics, cell therapy, and viral vector needs.Created via the Biologics Price Competition and Innovation Act, the biosimilar class of drugs was conceived as an opportunity to introduce competition for commonly used biologics following loss of patent protection and market exclusivity, similar to the generic paradigm that has helped sustain access and innovation for more than 3 decades. While our analytical development services are part of a comprehensive development and manufacturing program, they can also be offered as standalone services. Protein intact mass profiling by LC-TOF MS Peptide mapping by LC-MS/MSĬD, fluorescence, and FTIR for secondary/tertiary structure characterizationĬellular-Based Assays and Stability Activitiesġ60+ Custom In-House Analytical Tests for Clinical and Commercial Supply for Cell Therapy and Viral Vector products Key Analytical Development CapabilitiesĬarbohydrate analysis (quantitative sialic acid and monosaccharide analysis, N-glycan profiling) With our talented staff, fully equipped labs, and extensive experience with molecules from antibodies to complex glycoproteins, to cell therapy and viral vector products, AGC Biologics is your number one resource for analytical characterization. We routinely coordinate our protein, cell therapy, and viral vector characterization activities with Process Development to monitor quality attributes throughout the development process. Our methods are applied to final product characterization, reference material qualification, and comparability studies. Our broad analytical characterization capabilities allow us to characterize carbohydrates, verify primary structure, identify post-translational modifications, and more. This speeds results and eliminates the need for third-party interactions. Our in-house bioassay group specializes in the development and validation of cell-based assays. Robust and validated release methods, including bioassays, are designed to ensure your product's identity, safety, purity, and potency. AGC Biologics develops analytical methods for product release, characterization, and process development support.
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December 2022
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