Equipment design and facility layout for flexible biomanufacturing processes

摘要

In process development and manufacturing, the biopharmaceutical industry requires high flexibility in its production facilities. These suites must be capable of producing clinical material or even drug substances for the market. Several products are manufactured in parallel or shortly after one another, which is challenging especially for the equipment. Product titers are increasing due to improved cell line performances, and personalized medicine will lead to tailor-made drugs for a smaller group ofpatients. The resulting reduced upstream volumes enhance the opportunities for complete single-use manufacturing trains. These requirements must be considered already during the design phase of the manufacturing facility. Engineering efforts have to bereduced as much as possible in order to reduce cost and timelines. Generic platform concepts for the overall process enable a shorter execution time as well as more efficient qualification procedures. In this contribution, the focus is on production processes for monoclonal antibodies (mAb) as a major product class of the biopharmaceutical industry. Two case studies introduce process platform concepts integrating single-use equipment for an existing building and for a greenfield facility.