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Development of an Analytical Toolbox for the Assessment of Complex Biologics
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| 3.86 MB | Adobe PDF |
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"The biopharmaceutical industry is expanding rapidly and currently accounts for about 20% of the pharmaceutical market. Clinical and manufacturing processes for biologics, such as recombinant proteins or therapeutic monoclonal antibodies (mAbs), are lengthy, complex, and must meet safety and efficacy standards. As the complexity of the therapeutic products increases, the characterization becomes even more challenging, requiring the development of advanced analytical methodologies with increased sensitivity, throughput, and time/cost-effectiveness. Product heterogeneity (such as glycoforms, post-translational modifications, and sequence variants), and process-related impurities such as host cell proteins (HCP), are key product attributes that need to be monitored. ELISA-based HCP assays, commonly used for total HCP quantification, present several drawbacks, namely, not identifying individual HCPs, nor distinguishing their relative abundances.(...)"
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Palavras-chave
monoclonal antibodies host cell protein SWATH-MS absolute quantification average curve