Innovative technologies applied in the advanced bioprocess development and manufacturing

Recent years, with frequent outbreaks of epidemic diseases, importance of providing vaccine products within short timeframe to overcome these tragedies is well recognized. However, traditional technologies for bioprocess development and manufacturing are time-consuming and will not succeed in winning this war. Healthcare companies and US Department of Human Health and Service (HHS) started working on new technologies for the advanced development and manufacturing (ADM). The ADM platform is expected to significantly reduce the timeline from lab to production, and to produce diverse products flexibly in parallel. Some technologies, such as the micro/mini bioreactors for high-throughput process development (HTPD), and innovative methodologies for process optimization, have been applied to achieve these goals.  

As a critical component of the ADM platform, micro-/mini- bioreactors have been adopted in high-throughput strain screening, and HTPD. It significantly improves the efficiency from process development to up-scale manufacturing, resulting in shortened timeline for product commercialization.

This article also introduced new methodology applied for ADM.  A novel methodology based on system theories and principles, rather than traditional statistics-based DoE (Design of Experiment), has been used for optimizing complex fermentation process (up to 60s parameters) within a dozen of experimental runs. The novel methodology enabled optimization of complex system and achieved higher titer compared to the optimization performed with statistics DoE method.

These new technologies already made significant progress in the bioprocess development and manufacturing for the next generation vaccine production, and it starts to impact on the entire bioprocess and bio-manufacturing field.