Bio-Techne, Refeyn Partner on Workflow for Bispecific Antibody, Biosimilar Characterization

Why It Matters

The ability to characterize charge and size variants together speeds biopharma development, cuts costs, and mitigates late‑stage failure risk for the fast‑growing bispecific antibody market.

Key Takeaways

• Integrated icIEF and mass photometry workflow characterizes charge and size variants
• Single-molecule resolution achieved in four hours with nanogram samples
• Enables direct correlation of charge heterogeneity with aggregation
• Reduces reliance on multiple assays, accelerating biopharma development
• Supports faster risk mitigation for bispecific antibodies and biosimilars

Pulse Analysis

The bispecific antibody market is expanding rapidly, with global sales projected to exceed $10 billion by 2030. Unlike conventional monoclonal antibodies, bispecifics combine two distinct binding sites, creating a complex mixture of charge and size variants that can affect efficacy and safety. Traditional analytical pipelines often require separate assays—iso‑electric focusing for charge, size‑exclusion chromatography for aggregation—leading to long turnaround times and large sample demands. As developers race to bring these next‑generation therapeutics to patients, a unified approach that simultaneously resolves charge heterogeneity and molecular weight is becoming essential.

Bio‑Techne’s MauriceFlex icIEF system and Refeyn’s TwoMP mass‑photometry platform now form a seamless workflow that delivers that capability. The process begins with nanogram‑level fractions separated by capillary isoelectric focusing, after which each fraction is deposited onto a glass surface for single‑molecule mass photometry. Within four hours, researchers obtain a detailed map linking each charge variant to its exact mass and aggregation state, a resolution previously attainable only with multiple, time‑consuming experiments. The nanogram sample requirement also preserves precious material, a critical advantage during early‑stage development.

The combined solution promises to shorten development cycles and lower the risk of late‑stage failures, a key cost driver in biologics pipelines. By collapsing several assays into one, biopharma teams can make formulation and manufacturing decisions earlier, improving process robustness for both bispecific antibodies and biosimilars. Moreover, the workflow’s scalability and compatibility with existing laboratory automation suggest rapid adoption across R&D sites. As regulatory agencies increasingly scrutinize product heterogeneity, tools that provide comprehensive, high‑resolution characterization will likely become a new standard for biologics analytics.