Industry experience with autologous cell therapies is matching up with that of regulators in underscoring the importance of comprehensive integrated planning – encompassing internal operations and facility design as well as the complexities of the supply chain – to be able to meet future capacity needs.
During a facility design-focused session at a CASSS Symposium on cell and gene therapy (CGT) products, held in Bethesda, Maryland on June 10-12, Autolus Engineering and Supply Chain VP Aaron Vernon echoed the regulators at the session in stressing that, given the inherent complexities of CGT manufacturing – and particularly of autologous cell therapies – this upfront integration planning is critical to avoid dangerous bottlenecks as processing expands.
Facility and operational designs for generating autologous products, he noted, are inextricably linked. “Getting the operations and engineering to mesh together is really the difference between being able to make the product and meet our patient demand – or not,” he said.
Vernon brought Autolus’ and his own extensive biotech manufacturing, facility, and supply chain experience across different companies to bear in addressing the integration of the design of facilities and operations for autologous cell therapies.
His central message on the importance of early planning closely mirrored that offered previously at the session by FDA Center for Biologics Evaluation and Research (CBER) Division of Manufacturing and Product Quality (DMPQ) Consumer Safety Officer Lilly Koo, based on DMPQ’s and her own expanding engagement with the facility inspection and review process for CGTs (see IPQ October 11, 2019).
The FDA regulator also stressed the critical nature of early consideration of engineering and capacity needs in being able to avoid later bottlenecks and successfully deliver the life-saving CGT products to patients.
The message came through again in the third presentation at the session, in which industry consultant Annie Reitveld provided an EU regulator perspective on the design considerations for CGT manufacturing facilities and the handling of the aseptic and concurrent manufacturing challenges involved. Rietveld’s biotech credentials include work in Europe as a qualified person for several companies, 16 years as an inspector for the Dutch health inspectorate, and participation on the working team for Europe’s Advanced Therapy Medicinal Product (ATMP) guideline (see ibid.).