Bio?Techne and Refeyn Close Critical Gap in Bispecific Antibody and Biosimilar Characterization

Bio?Techne and Refeyn Close Critical Gap in Bispecific Antibody and Biosimilar Characterization

  • New integrated workflow combines icIEF fractionation and mass photometry
  • Enables direct characterization of aggregation and size within icIEF-resolved charge variants
  • Four-hour workflow reduces development risk and accelerates biosimilar manufacturing

- Bio‑Techne Corporation (NASDAQ: TECH), a global provider of life science tools, reagents and diagnostic products, and Refeyn, the pioneer in mass photometry technology, today announced a first‑of‑its‑kind integrated workflow for the characterization of charge and size variants in bispecific antibodies and biosimilars.

By combining R&D Systems MauriceFlex™ imaged capillary isoelectric focusing (icIEF) fractionation system with Refeyn's TwoMP mass photometry platform, researchers can directly correlate charge heterogeneity with molecular weight and aggregation at single‑molecule resolution in a streamlined four‑hour workflow.

Bispecific antibodies are among the fastest-growing classes of biotherapeutics, but their structural complexity makes thorough characterization challenging. 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. However, analyzing the size and aggregation of individual charge fractions has historically been difficult due to the large sample requirements of traditional methods.

The integrated workflow addresses this challenge directly by pairing icIEF fractionation with mass photometry. Charge variants are first separated using MauriceFlex™, then analyzed on Refeyn'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.

"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.

"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," said Will Geist, President Bio‑Techne Protein Sciences Segment.

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 is available here.

The workflow will also be presented at the American Society for Mass Spectrometry (ASMS) conference, taking place May 31 – June 4, 2026, in San Diego. See booth and poster details here

ABOUT BIOTECHNE

Bio‑Techne Corporation (NASDAQ: TECH) is a global life sciences company headquartered in Minnesota, celebrating 50 years of empowering scientific and diagnostic communities to reach better answers. The company provides high‑quality reagents, analytical instruments, and precision diagnostics. Its portfolio is organized into three customer‑focused brands: R&D Systems™, Bio‑Techne Spatial™, and Bio‑Techne Diagnostics™, reflecting the scientific journey from discovery to translational research to clinical decision making. Bio‑Techne operates in 34 locations worldwide and employs approximately 3,000 people. In fiscal year 2025, the company generated over $1.2 billion in net sales. Its more than 500,000 products are used globally by academic researchers, biopharmaceutical and biotechnology companies, and clinical diagnostic laboratories.

For more information on Bio‑Techne, please visit www.bio-techne.com or follow the company on LinkedIn, X, or YouTube.

ABOUT REFEYN

Refeyn specializes in the development, production, and distribution of mass photometry solutions for industry and academia. Its innovative technology enables accurate mass measurement of single molecules in their native state without labels, delivering faster insights with minimal sample compared to conventional methods.

For more information on Refeyn, please visit www.refeyn.com or follow the company on LinkedIn or YouTube.

MEDIA CONTACTS:

BioTechne
David Clair, Vice President Investor Relations
IR@bio-techne.com 

Corporate Communications
media.relations@bio-techne.com 

Refeyn
Catie Lichten
Scientific Communications Manager
catie.lichten@refeyn.com 

 

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/biotechne-and-refeyn-close-critical-gap-in-bispecific-antibody-and-biosimilar-characterization-302791071.html

SOURCE Bio-Techne Corporation

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