What's Happening?
Bio-Techne and Refeyn have announced a new integrated workflow designed to enhance the characterization of bispecific antibodies and biosimilars. This collaboration combines Bio-Techne's R&D Systems MauriceFlex imaged capillary isoelectric focusing (icIEF)
fractionation system with Refeyn's TwoMP mass photometry platform. The workflow allows researchers to correlate charge heterogeneity with molecular weight and aggregation at a single-molecule resolution within four hours. This development addresses the challenges posed by the structural complexity of bispecific antibodies, which can delay development and increase manufacturing risks. The new system requires only a nanogram-level sample and provides detailed insights into size distribution and aggregation, reducing the need for multiple tests and supporting faster process development.
Why It's Important?
The introduction of this workflow is significant for the biopharmaceutical industry, particularly in the development of next-generation antibodies. Bispecific antibodies are a rapidly growing segment, but their complexity makes them difficult to characterize, which can lead to costly delays and failures in drug development. By enabling more efficient and comprehensive characterization, this workflow helps reduce risks and costs associated with the development of these complex molecules. It also supports better decision-making earlier in the development process, which can accelerate the time to market for new therapies. This advancement is likely to benefit pharmaceutical companies by improving the efficiency and reliability of their research and development efforts.
