Advanced Bioprocess Development and Biomanufacturing Technologies and High Throughput Miniature Bioreactors

Abstract

In recent years, the importance of a rapid response to influenza pandemics has been widely recognized. However, traditional technologies for bioprocess development and manufacturing are unable to meet such a rapid response. Healthcare companies and related organizations in the United States, including the US Department of Health and Human Services, have proposed and initiated the development of a next-generation technology platform for advanced bioprocess development and manufacturing (ABDM). The goal of ABDM is to reduce the timeframe significantly for bioprocess development and manufacturing, enabling a prompt response to influenza pandemics and preventing them from spreading. Concurrently, developments in precision medicine have presented new demands for the biopharmaceutical industry. The small-scale production and fast turnaround time required in precision medicine have subsequently required an accelerated development and manufacturing timeframe. At the same time, the number of product subgroups will increase, and the batch sizes and final product amounts will decrease. To satisfy these production and turnaround time requirements, ABDM uses micro-and mini-bioreactors. Specifically, the major features of the ABDM technology platform include high-throughput screening and process development based on micro-and mini-bioreactors, disposable technologies, modular unit operations, and flexible manufacturing. The development of ABDM in China will directly strengthen national security, improve public welfare, and provide great social and economic value. The impact of this next-generation technology platform will spread throughout the entire biomanufacturing industry and mark a new era for bioprocess development and manufacturing.