Use of the ambr®250 in Combination with High-Throughput Design and Analysis Tools for Rapid, Scalable USP Development

There have been many recent advances in high throughput (HT) technologies for upstream development, enabling processes to be developed in a fraction of the time compared with conventional methods. However, when applying this technology to biotherapeutic drug development, the suitability of the systems for developing large scale manufacturing processes and meeting regulatory demands needs to be demonstrated and ensured. Inclusive approaches encapsulating platform expression systems and fermentation technologies, parallel bioreactor systems, high throughput analytics and sophisticated design and data handling tools can ensure these regulatory demands are met.

This white paper explores using the ambr®250 (24-way) parallel bioreactor system in combination with HT analytics tools (e.g. the Cedex BioHT analyser and Caliper electrophoresis system) to enable rapid analysis of samples. Experimental design and visual analytics software packages such as Design Expert® and JMP® enable this information to be easily visualized, interpreted and modeled to improve process knowledge. Combined with Design of Experiments (DoE) and Quality by Design (QbD) principles and platform fermentation technologies, it enables rapid progression from gene to optimized high titer fermentation processes, maintaining the high levels of process understanding required to meet regulatory requirements and with earlier process optimization, which lowers regulatory risk.

This approach has been applied successfully by FUJIFILM Diosynth Biotechnologies in combination with its proprietary pAVEway™ expression system and platform fermentation technology to obtain high titer, robust and well characterized fermentation processes suitable for CGMP manufacture of biotherapeutic drug products.