#USA #Minneapolis #Bio-Techne #Refeyn #Antibody Analysis

Efficient Antibody and Biosimilar Characterization: A New Era

In a remarkable partnership, Bio-Techne Corporation and Refeyn have introduced a state-of-the-art integrated workflow that significantly enhances the characterization process of bispecific antibodies and biosimilars. This innovative collaboration marks a pivotal moment in biopharmaceutical development, addressing a critical gap in characterization methods.

The Challenge of Characterization

Bispecific antibodies are among the fastest-evolving classes of therapeutics, gaining traction due to their potential to combat complex diseases. However, their intricate structures make thorough characterization essential yet challenging. The risks associated with incomplete characterization can lead to costly delays and failures in the manufacturing process.

To overcome these challenges, the duo has developed a first-of-its-kind workflow that efficiently combines imaging capillary isoelectric focusing (icIEF) with mass photometry. This new methodology allows researchers to analyze charge variants alongside their molecular weights and aggregation characteristics simultaneously.

A Seamless Four-Hour Workflow

The new workflow takes only four hours and allows scientists to profile charge heterogeneity with unprecedented resolution. The MauriceFlex™ icIEF system effectively separates charge variants of antibodies, a step critical for compliance with regulatory requirements. Traditionally, analyzing the size and aggregation of these variants was cumbersome and demanding due to sample size restrictions.

By integrating Refeyn's TwoMP mass photometry platform, the process now requires an impressively minimal sample size—only nanograms—enabling faster insights into molecular behavior. Charge variants are first separated using the high-resolution MauriceFlex™ system, then analyzed with the TwoMP platform, leading to direct characterization that was previously unachievable with standalone systems.

Benefits for Researchers and Manufacturers

This joint effort addresses one of the industry’s most significant hurdles by allowing for simultaneous interrogation of charge and size variants in a streamlined workflow. Gerry Mackay, CEO of Refeyn, stated, "Researchers can now interrogate charge and size variants together in a single workflow, which is crucial for characterizing bispecifics that are complex in nature."

Bio-Techne’s President, Will Geist, emphasized the importance of this development for the industry. As pressures mount for biopharmaceutical companies to innovate and bring products to market faster, this streamlined process not only reduces risks but also controls costs effectively by providing better data early in the development phase.

Real-World Application and Future Prospects

The efficacy of this workflow was demonstrated in a recent joint webinar, during which scientists tracked size-related changes in the bispecific antibody Mosunetuzumab-axgb as well as a biosimilar. Detailed findings from this research will be available in an application note, showcasing the method's capability to analyze complex variants under multiple conditions.

Furthermore, the significance of this integrated workflow will be highlighted at the American Society for Mass Spectrometry (ASMS) conference scheduled for May 31 to June 4, 2026, in San Diego, where attendees will gain insights into the practical applications and advantages of this technology.

Conclusion

The collaboration between Bio-Techne and Refeyn is set to redefine the standards of antibody characterization. By combining cutting-edge technologies, the partners have created a methodology that not only accelerates development timelines but also enhances the accuracy and reliability of biologics characterization. As the demand for bispecific antibodies continues to grow, such innovations will be crucial in navigating the complexities of therapeutic production while ensuring safety and efficacy in treatment options for patients worldwide.