Recombinant Protein for Textile
E. coli Expression System
The client had independently developed and established an in-house bioproduction process at a 300L scale. Although the upstream process was functional, the downstream operations were not optimized due to the absence of scalable DSP equipment, rendering the process unsuitable for industrial scale-up.
To overcome these constraints, the client engaged us to optimize the full production workflow and enable a robust manufacturing strategy. The project centered on E. coli bioprocess scale-up from 300L to 1,000L, combining upstream performance enhancement with downstream process redesign to ensure industrial scalability.
Process Development & Optimization
A comprehensive process optimization program was initiated, addressing both upstream and downstream operations.
On the upstream side, multiple Design of Experiments approaches were implemented to systematically evaluate process parameters, resulting in a yield increase of approximately 10% and significantly improving overall process efficiency and robustness.
In parallel, a robust and scalable downstream process was developed. The implementation of disc-stack centrifugation significantly improved separation performance and process scalability. Through process redesign and optimization, our team successfully shortened the DSP workflow by more than 50%, leading to a substantial reduction in the final product cost.
Following the E. coli bioprocess scale-up optimization, production was successfully scaled to a 1,000L fermenter, demonstrating industrial readiness and positioning the process for regulatory submission.
Scale-Up
Following process optimization, the production was successfully scaled to a 1,000L fermenter, positioning the process for regulatory submission.
In addition, a roadmap for further scale-up to a 15,000L fermenter has been approved.
