Drug companies are under pressure to improve manufacturing processes. The FDA and the European Medicines Agency (EMA) have both expressed support for modern methods, citing product quality and supply stability benefits. However, although industry is responding, currently available analytics technologies need to improve for drug companies to fully embrace the quality-be-design approach, says Phil Vanek, PhD, CTO at Gamma Biosciences.
“The biopharma industry continues to express interest in technologies that enable process control and improve process development timelines, but never compromise on critical quality attributes. Because process analytics include a variety of testing modalities spanning the entire range of unit operations in bio production, as well as in-line, on-line, and at-line testing, the PAT percentage of application in the industry is quickly nearing 100%,” he continues.
“Despite this demand—which is starting to transition from an enabler to a competitive advantage for process success—there is a large unmet need for accurate, real-time, in-line analytics that are both simple to implement and cost effective.”
To try and address this market need, Gamma Biosciences last month made a strategic investment in Nirrin Technologies, a developer of near infrared-based process monitoring technologies. Nirrin’s approach, says its CEO Jonathan Hartmann, is designed to help biopharmaceutical companies making complex, modern therapies meet regulatory demands for more comprehensive process data.
“While advanced therapies are making steady progress in development and adoption, the regulatory bodies overseeing them are challenged in addressing how these novel therapies can be made efficiently, yet still be safe and effective,” he tells GEN. “To address these challenges, therapeutic developers need to focus on therapeutic potency which, for these therapies, is often predicated on the manufacturing process itself. Process analytics promise to improve not only the therapeutic potential of these medicines, but also the ability to assure their safety through process consistency and control, as well as their cost effectiveness through automation and simplified manufacturing.”
The “tunable” sensing technology is used for the direct measurement of analytes or bioprocess phenomena to provide “deep insights into bioprocess manufacturing conditions, and real-time on-line analytics and control,” according to Hartmann.
And such real-time insights are likely to be in demand, adds Vanek, noting that “The sensor technologies on the market today are costly, slow, and/or complex, and often measure surrogate events in the process which are then indirectly correlated to the desired metric. Nirrin is overcoming these challenges with measurement and control strategies that deliver total and viable cell density, glucose, protein concentration, and aggregation data.”