Bio-Techne Introduces Advanced Workflow for Bispecific Antibody and Biosimilar Characterization

Bio-Techne (TECH) unveils a groundbreaking workflow aimed at transforming the characterization of bispecific antibodies and biosimilars. This innovative approach combines Bio-Techne's R&D Systems MauriceFlex imaged capillary isoelectric focusing (icIEF) fractionation system with Refeyn's TwoMP mass photometry technology, marking a significant advancement in the biotech field. The collaboration allows scientists to directly associate charge heterogeneity with molecular weight and aggregation, providing data at a single-molecule resolution. This efficient process not only reduces the timeframe for analysis to a mere four hours but also lowers development risks, thus expediting the production of critical biosimilars.

Overcoming Challenges in Bispecific Antibody Development

The integration of these technologies addresses the inherent challenges associated with bispecific antibodies, which, due to their complex structures, can lead to delays and costly failures in development. Historically, characterizing such intricate molecules poses significant obstacles, particularly in assessing charge variants required by regulatory bodies. The MauriceFlex system specializes in the nuanced separation of charge variants while traditional methods fall short regarding sample size requirements for effective analysis. The new workflow mitigates these limitations, enabling scientists to analyze icIEF-resolved charge fractions utilizing nanogram-level samples on the TwoMP platform, unlocking a detailed understanding of size and aggregation characteristics that were previously unattainable with conventional techniques.

Expert Praise for Innovative Workflow

Industry experts have hailed this collaborative development as a pivotal step towards more efficient biologic development processes. With growing interest and commitment to advancing biopharmaceutical research, the new workflow is set to make a notable impact in the biosimilars market. Demonstrations of this technology are slated for the upcoming ASMS conference, where stakeholders will get a firsthand look at the potential of this integrated solution to facilitate faster development cycles and ultimately improve patient outcomes.