Continuous biopharmaceutical production with single-use equipment
Continuous processes are becoming increasingly important in biopharmaceutical production. Experts have now analysed a continuous biopharmaceutical model process with single-use systems in a paper designed "by experts - for experts". The current state of the art and potentially associated technical risks are systematically examined for each process step and mitigation strategies are discussed.
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. However, biopharmaceutical companies implementing continuous technologies at manufacturing scale under current GMP (cGMP) conditions are also obliged to address the potential risks.
Experts from the DECHEMA working group "Single-use technology in biopharmaceutical manufacturing" now investigate, in a freely available publication, the technical risks and questions associated with continuous biomanufacturing using single-use equipment. For this purpose, they performed a systematic risk analysis and prioritization through a failure mode and effects analysis (FMEA) for a monoclonal antibody process at 500 L production scale.
For every upstream and downstream processing step of this model process, 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.
The paper published in March 2020 is designed "by experts - for experts". It is particularly aimed at experts in the development and implementation of continuous biopharmaceutical processes, plant designers and engineers. With this comprehensive analysis, the authors aim to contribute to the harmonization of efforts towards the implementation of continuous processing technologies in biopharmaceutical manufacturing.