Innovating The mAb Characterization Process

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The development of protein-based biopharmaceuticals involves navigating genetic variations and post-translational modifications (PTMs), which collectively define a molecule’s "personality." Recognizing these distinct features guides the creation, production, and evaluation techniques employed to assess and manage quality attributes and testing standards. During biopharmaceutical production, it is essential to control variables like cell line and process conditions to avoid introducing unwanted variations. However, traditional methods for testing charge variants, such as chromatographic or electrophoretic techniques, are time-consuming and often delayed until the later stages of development. In the fast-paced world of biopharma, the ability to quickly analyze proteoforms can significantly decrease development timelines. This piece discusses the challenges faced by researchers in the research and development process and highlights a case study from FUJIFILM Diosynth Biotechnologies. By leveraging innovative technology, the company was able to overcome unexpected results and expedite testing, bypassing months of laborious analysis. Learn more about how disruptive technologies can streamline biopharmaceutical development, improving efficiency while accelerating the time to market for viable drug candidates.