Bio-Techne and Refeyn Launch First Integrated Workflow for Bispecific Antibody and Biosimilar Characterization
核心洞察
Bio-Techne and Refeyn (搜索) announced a first-of-its-kind integrated workflow combining icIEF fractionation with mass photometry for characterizing charge and size variants in bispecific antibodies and biosimilars.
The four-hour workflow enables direct correlation of charge heterogeneity with molecular weight and aggregation at single-molecule resolution using only nanogram-level samples.
The integrated approach addresses a critical gap in bispecific antibody characterization, where structural complexity has historically delayed development and increased manufacturing risk.
Bio-Techne Corporation (搜索) and Refeyn (搜索) have announced a first-of-its-kind integrated workflow that closes a critical gap in the characterization of charge and size variants in bispecific antibodies and biosimilars. The collaboration combines Bio-Techne's R&D Systems MauriceFlex™ imaged capillary isoelectric focusing (icIEF) fractionation system with Refeyn's TwoMP mass photometry platform, enabling researchers to directly correlate charge heterogeneity with molecular weight and aggregation at single-molecule resolution in a streamlined four-hour workflow.
Addressing a Pressing Analytical Challenge
Bispecific antibodies represent the fastest-growing class of biotherapeutics, yet their structural complexity poses significant characterization challenges. Incomplete characterization can delay development, increase manufacturing risk, and lead to costly late-stage failures. The MauriceFlex™ system delivers high-resolution separation and fractionation of charge variants—a capability increasingly expected in regulatory submissions—but analyzing the size and aggregation of individual charge fractions has historically been difficult due to the large sample requirements of traditional methods.
The new integrated workflow directly addresses this limitation. Charge variants are first separated using MauriceFlex™, then analyzed on Refeyn (搜索)'s TwoMP platform, which requires only nanogram-level sample and reveals size distribution and aggregation at single-molecule resolution. Together, the technologies enable direct characterization of aggregation and size within icIEF-resolved charge variants—an insight not accessible with standalone methods—reducing reliance on multiple tests and enabling faster, more efficient process development.
Industry Leaders Weigh In
"Bispecifics are the fastest growing segment within next-generation antibodies, but they are very difficult to characterize. This approach directly addresses one of the biggest challenges by combining icIEF fractionation with mass photometry. Researchers can now interrogate charge and size variants together in a single workflow," said Gerry Mackay, CEO of Refeyn (搜索).
Will Geist, President of Bio-Techne's Protein Sciences Segment, emphasized the practical implications for drug developers: "Our customers are under intense pressure to develop and manufacture increasingly complex biologics faster and more efficiently. Enabling deeper characterization with less sample helps them reduce risk, control costs, and make better decisions earlier in development."
Demonstration and Scientific Validation
In a joint webinar, scientists demonstrated the workflow using Mosunetuzumab-axgb and a biosimilar, tracking size-related changes in the molecule across charge variant fractions under multiple conditions. An application note with full findings has been made available. The workflow is also being presented at the American Society for Mass Spectrometry (ASMS) conference, taking place May 31 through June 4, 2026, in San Diego.
About the Companies
Bio-Techne Corporation (搜索) (NASDAQ: TECH), headquartered in Minnesota, is a global life sciences company celebrating 50 years of empowering scientific and diagnostic communities. The company operates in 34 locations worldwide, employs approximately 3,000 people, and generated over $1.2 billion in net sales in fiscal year 2025. Its portfolio is organized into three customer-focused brands: R&D Systems™, Bio-Techne Spatial™, and Bio-Techne Diagnostics™.
Refeyn (搜索) specializes in the development, production, and distribution of mass photometry solutions for industry and academia. Its technology enables accurate mass measurement of single molecules in their native state without labels, delivering faster insights with minimal sample compared to conventional methods.