Recombinant Bio-pesticide
P. pastoris Expression System
The client approached us with a recombinant strain that had already been developed and validated at small scale. However, the existing process was not scalable.
The fermentation required optimization, and the downstream process (DSP) consisted of a single separation step performed using a laboratory-scale centrifuge. A robust and scalable manufacturing strategy was required to enable further development and field deployment.
Process Development & Optimization
Our team initiated a comprehensive optimization program focused on improving fermentation performance while establishing a scalable downstream manufacturing strategy.
The fermentation process underwent systematic optimization through multiple Design of Experiments (DoE) approaches, allowing us to evaluate critical process parameters and identify conditions that enhance productivity. In parallel, different feeding regimes were assessed and compared in order to achieve maximal yield and ensure process robustness.
On the downstream side, the original single step laboratory scale separation process was replaced with a robust and scalable DSP strategy. The implementation of disc-stack centrifugation combined with filtration enabled improved separation efficiency and laid the foundation for industrial-scale processing.
In addition, a stable freeze-drying protocol was established to ensure product stability. To further optimize manufacturing economics, a scalable spray-drying protocol is currently under development with the objective of reducing the final product cost.
Scale-Up
The optimized process was successfully scaled to a 1,000L fermenter, enabling the production of kilogram quantities of protein for field testing.
In parallel, a roadmap for scale-up to a 15,000L fermenter has been developed and approved by the client.
