Recipharm Advanced Bio to deliver PAT seminar series to FDA staff

Recipharm Advanced Bio, the advanced therapy medicinal products (ATMP) division of Recipharm, announced it will deliver a multi-part educational seminar series to scientific staff at the U.S. Food and Drug Administration focused on next-generation testing enabled by process analytical technology (PAT), digital manufacturing, and advanced analytics.

The seminars, part of the FDA’s Center for Biologics Evaluation and Research (CBER) Advanced Manufacturing Seminar Series, will center on Recipharm Advanced Bio’s modular “lab on wheels” PAT framework. The mobilized platform is designed to integrate in-line and at-line analytics, real-time data modeling, and digital control strategies directly into biologics manufacturing environments.

According to the company, advanced PAT systems can enable continuous process verification and create the potential for real-time release by shifting from traditional off-line testing toward in-process monitoring and enhanced process understanding. Planned topics for the seminars include validation and bridging strategies between off-line and in-process analytical methods, digital twins for real-time monitoring, and considerations for modular analytical systems in biologics production.

The seminar content builds on prior federally supported work, including a 2023 FDA contract led by MIT and conducted by Recipharm Advanced Bio with academic collaborators. That project supported development of a continuous, integrated manufacturing platform for lipid nanoparticle-encapsulated xRNA production incorporating inline PAT and novel control software. Insights from the program have informed the company’s Recimagine solutions for continuous production and digital process development, according to Recipharm Advanced Bio.

The company noted that participation in the seminar series does not constitute FDA endorsement of any specific technology or approach.

The announcement follows recent activity by parent company Recipharm. In February 2026, Recipharm announced an investment to expand high-potency oral solid dose capabilities at its Leganés, Spain facility, adding clinical and pilot-scale capacity to support development through commercial supply. 

The CDMO also recently completed the sale of its Yavne, Israel API development and small-scale manufacturing site to Scinai Immunotherapeutics, while establishing a long-term CDMO collaboration focused on early-stage development in Israel and late-stage and commercial manufacturing through Recipharm’s broader network.