In recent years, continuous manufacturing has been gaining momentum in the biopharmaceutical industry. Among the advantages are improved process productivity, enhanced flexibility and cost savings. Experts from the working group “Single-use technology in biopharmaceutical manufacturing” now investigate the technical risks and questions associated with continuous biomanufacturing using single-use equipment. A systematic risk analysis and prioritization through a failure mode and effects analysis (FMEA) is performed for a monoclonal antibody process at 500 L production scale. For every upstream and downstream processing step, the technical state-of-the-art, most prominent risks and mitigation strategies are discussed. The mitigation strategies summarize suggestions from industrial and academic end-users, as well as suppliers and take statements from regulatory authorities and existing guidelines from further industry collaborations into consideration.
publishing date March 2020