Advanced Bioprocess Development and Biomanufacturing Technologies and High Throughput Miniature Bioreactors

Abstract

In recent years, the importance of rapid response time to virulent infectious disease is widely recognized. However, the traditional technologies for bioprocess development and manufacturing will not succeed in winning this war. US healthcare companies and related organizations including US Department of Human Health and Service, proposed and started working on the next generation of technology platforms for advanced bioprocess development and manufacturing (ABDM).The development of ABDM is to significantly reduce the timeframe for bioprocess development and manufacturing, making it possible to promptly respond to outburst of pandemic influenza and prevent it from outspreading. Meanwhile, the development of precision medicine also presents new demands to the biopharmaceutical industry. With the demand of small-scale production and fast turn-around time of precision medicine, the duration of development and manufacturing needs to be accelerated significantly. At the same time, the number of sub-groups of the product would increase, and the batch sizes and amount of final product would decrease, as well. To satisfy the demands of small-scale production and fast turnaround time of ABDM, micro- and mini-bioreactor is the key equipment. The major technologies of ABDM include high throughput screening and process development based on micro- and mini-bioreactors, disposable technology, modular unit operations and flexible manufacturing. The development of ABDM will directly strengthen the National Security, improve the welfare of the people, and it also provides great social and economic values. The impact of this platform will radiate to the entire biomanufacture industry, and open a whole new era for the bioprocess development and bio-manufacturing.