NIIMBL-facilitated active listening meeting between industry and FDA identifies common challenges for adoption of alternative and rapid microbiological methods.

Abstract

Alternative and rapid microbiological methods (ARMM) used in biopharmaceutical manufacturing have potential advantages over current compendial methods in that they can enable faster product release and improved process monitoring and quality assurance. There is value in community-wide discussion on ARMMs to help understand the challenges of ARMM adoption in biopharmaceutical manufacturing. The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) attempted to understand the successes and challenges around ARMM adoption through surveys, interviews, and a facilitated Active Listening Meeting between industry and FDA representatives. Through these interactions, it was observed that many organizations have successfully implemented ARMMs in approved manufacturing processes, suggesting an absence of significant regulatory obstacles to implementation. Further, five key elements impacting technology adoption were identified: technology readiness, vendor support, organizational adoption readiness, business case/economics, and regulatory interaction. The Active Listening Meeting format proved valuable for fostering honest and informal conversations between both sponsors and regulators.