A Streamlined Workflow for the Determination of Intact Mass Measurement of Monoclonal Antibodies
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Biotherapeutics, including mAbs, biosimilars, ADCs, and nucleotide-based therapies, require precise characterization to ensure safety, efficacy, and regulatory compliance. Throughout development, manufacturing, and storage, these products can undergo modifications, making it essential to monitor impurities and microheterogeneity. Regulatory guidelines mandate the accurate analysis of post-translational modifications (PTMs), particularly glycosylation, due to their significant impact on biological function. At ARL Biopharma, we offer comprehensive biotherapeutic characterization using advanced mass spectrometry, liquid chromatography, and capillary electrophoresis. Our regulatory compliant workflows enable precise assessment of PTMs, glycosylation, and impurities while ensuring seamless data acquisition, processing, and reporting. By maintaining product integrity at every stage, we support pharmaceutical companies in meeting regulatory standards and delivering safe, effective therapeutics.