VALIDOGEN combines deep bioprocess engineering expertise with more than 15 years of experience in microbial protein production to develop robust, high-performance fermentation processes. Our process development approach focuses on maximizing protein yields, improving process robustness, reducing manufacturing costs, and enabling reliable scale-up and efficient technology transfer from development to industrial production.
VALIDOGEN supports clients in the development and optimization of E. coli fermentation and purification processes, designing robust protein production processes tailored to the specific requirements of each recombinant protein. With more than 15 years of experience in microbial protein production, VALIDOGEN provides process development expertise for a wide range of proteins across different industries.
Starting from existing production strains, we optimize cultivation conditions, feeding strategies, and process parameters to maximize productivity while ensuring stable and reproducible process performance.
Early consideration of scale-up parameters ensures that the developed processes can be successfully transferred from laboratory scale to pilot and industrial fermentation systems.
VALIDOGEN’s experts develop and optimize E. coli fermentation processes tailored to the requirements of your recombinant protein and production strain. Cultivation parameters such as feeding strategy and induction conditions are systematically optimized to maximize productivity, yield, and product quality. Depending on project objectives, process development can range from targeted parameter adjustments to comprehensive Design of Experiments (DoE) campaigns to identify optimal operating conditions.
A detailed understanding of fermentation performance is essential for robust recombinant protein production, providing the process knowledge required to define critical process parameters (CPPs) in alignment with Quality by Design (QbD) principles.
To ensure reliable production performance, repeated confirmation runs verify process robustness, reproducibility, and operational stability. This ensures that optimized E. coli production processes perform consistently across development and manufacturing scales.
VALIDOGEN supports clients with a seamless technology transfer, enabling a smooth transition from laboratory development to pilot or industrial manufacturing environments for scale-up.
We integrate our upstream process development with a variety of downstream purification strategies, including optimization of chromatographic steps, impurity clearance, and yield improvement.
VALIDOGEN’s experts develop and optimize E. coli fermentation processes tailored to the requirements of your recombinant protein and production strain. Cultivation parameters such as feeding strategy and induction conditions are systematically optimized to maximize productivity, yield, and product quality. Depending on project objectives, process development can range from targeted parameter adjustments to comprehensive Design of Experiments (DoE) campaigns to identify optimal operating conditions.
A detailed understanding of fermentation performance is essential for robust recombinant protein production, providing the process knowledge required to define critical process parameters (CPPs) in alignment with Quality by Design (QbD) principles.
To ensure reliable production performance, repeated confirmation runs verify process robustness, reproducibility, and operational stability. This ensures that optimized E. coli production processes perform consistently across development and manufacturing scales.
VALIDOGEN supports clients with a seamless technology transfer, enabling a smooth transition from laboratory development to pilot or industrial manufacturing environments for scale-up.
We integrate our upstream process development with a variety of downstream purification strategies, including optimization of chromatographic steps, impurity clearance, and yield improvement.
No, VALIDOGEN’s E. coli fermentation process development service is designed for clients who already operate established E. coli expression systems but require professional bioprocess development and optimization, scale-up strategies, and technology transfer support.
Project timelines depend on the scope and complexity of the development program required. Our suite of parallel bioreactor systems enables rapid testing of multiple conditions, allowing efficient optimization and accelerated process development.
VALIDOGEN develops fermentation and purification processes at scales up to 10 L. While VALIDOGEN is not a GMP manufacturing facility, we deliver robust processes that can be efficiently implemented under GMP at your selected CDMO or manufacturing partner.
Yes, we enable rapid production of initial recombinant protein samples using 1 L and 10 L bioreactor systems, providing sufficient material for early-stage evaluation and analysis. If required, proteins can be purified based on established standard purification techniques, ensuring fast delivery of analytically suitable material.
VALIDOGEN's expert team is happy to discuss your project and help find the right solution. Send any project related requests to project@validogen.com, directly to our scientists, or use our contact form.
