Rethinking Protein Quantitation for the Future of Biomanufacturing

As biologic therapies become more complex, manufacturers face increasing pressure to generate reliable analytical data while accelerating development timelines. Protein quantitation remains a fundamental step throughout bioprocess development, yet many traditional methods require extensive calibration, sample preparation, and specialized expertise, creating challenges as programs move from research into manufacturing.

In this video interview with BioPharm International^©, Bryan Hassell, founder and CEO of Nirrin Technologies, explains why simplifying protein quantitation has become an important priority for the industry. He discusses the limitations of conventional ultraviolet-based analytical methods, the operational impact of poor method transferability, and how new approaches could enable more consistent measurements throughout a product's lifecycle.

Why is method transferability becoming increasingly important for biomanufacturing?

According to Hassell, one of the biggest challenges facing manufacturers is maintaining continuity as analytical methods move across development, manufacturing, quality control, and multiple production sites.

Traditional protein quantitation methods often perform well within a single laboratory, he said, but transferring those methods frequently requires additional validation, user training, and workflow adjustments. As biologics become more sophisticated and development timelines continue to shorten, those inefficiencies can create significant operational burdens.

To address these limitations, Nirrin developed TALOS, a protein quantitation platform that uses near infrared spectroscopy rather than traditional ultraviolet absorption. Hassell explained that operating in a different wavelength range provides access to additional molecular information while reducing dependence on molecule-specific calibration for every new therapeutic protein.

He also emphasized that simplifying the user experience was a major design objective. Rather than requiring extensive sample preparation or instrument-specific expertise, the platform was designed to deliver rapid, repeatable measurements with minimal user input.

Beyond improving workflow efficiency, Hassell believes greater analytical consistency could have a broader impact across the biologics development process. Using a common analytical approach from early research through commercial manufacturing may help reduce method redevelopment, improve confidence in analytical data, and support better process understanding as products advance through development.

Looking ahead, Hassell sees protein quantitation evolving alongside broader trends in automation and digital manufacturing. As bioprocessing becomes increasingly data driven, analytical technologies that can provide consistent measurements across laboratories, manufacturing sites, and product stages may play a larger role in enabling faster development and more informed manufacturing decisions.

Watch the full interview to hear Hassell discuss the future of protein quantitation, the potential for real time analytical monitoring, and how advances in bioprocess analytics could reshape biologics manufacturing over the next decade.