Technical State-of-the-Art and Risk Analysis on Single-Use Equipment in Continuous Processing Steps

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

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