Bio-Techne and Refeyn Launch Integrated Workflow for Bispecific Antibody Characterization

  • Bio-Techne and Refeyn introduced a first-of-its-kind integrated workflow for characterizing charge and size variants in bispecific antibodies and biosimilars.
  • The workflow combines Bio-Techne's MauriceFlex™ icIEF fractionation system with Refeyn's TwoMP mass photometry platform, enabling single-molecule resolution analysis in a four-hour process.
  • The solution reduces development risk and accelerates biosimilar manufacturing by directly correlating charge heterogeneity with molecular weight and aggregation.
  • The workflow was demonstrated using Mosunetuzumab-axgb and a biosimilar, with findings presented at the ASMS conference (May 31 – June 4, 2026).

Bispecific antibodies are among the fastest-growing classes of biotherapeutics, but their structural complexity has historically posed challenges in characterization. This collaboration between Bio-Techne and Refeyn addresses a critical gap by streamlining the analysis of charge and size variants, reducing reliance on multiple tests, and enabling faster, more efficient process development. The solution is particularly timely as the biopharmaceutical industry faces increasing pressure to develop and manufacture complex biologics with greater efficiency and lower risk.

Adoption Pace
How quickly biopharmaceutical companies will integrate this workflow into their development pipelines, given the pressure to accelerate biosimilar manufacturing.
Regulatory Impact
Whether the direct characterization capabilities will become a standard requirement in regulatory submissions for complex biologics.
Competitive Response
The likelihood of competitors developing similar integrated solutions to address the growing demand for efficient bispecific antibody characterization.