VALIDOGEN turns your established E. coli or P. pastoris strain into a robust and scalable process for protein production - supported by 15 years of microbial bioprocess expertise.
VALIDOGEN supports process development for protein production by focusing on:
- Targeted process optimization to maximize productivity
- Process characterization aligned with QbD principles
- Robustness testing to ensure stable performance across parameter ranges
- Reproducibility verification through independent cultivation runs
- Transfer-ready process design and documentation for efficient scale-up
Whether working with E. coli or P. pastoris, our goal is the same: enabling efficient, scalable and reliable protein production through strong early-stage process design.
Key benefits of VALIDOGEN’s microbial process development service
Process development and optimization: VALIDOGEN systematically optimizes key cultivation parameters such as feeding strategy, induction conditions, media composition, temperature, pH, dissolved oxygen, and process controls to maximize yield, productivity, and product quality.
Process characterization and understanding: VALIDOGEN generates the process knowledge needed to define critical process parameters, supports Quality by Design principles, and establishes a well-characterized basis for scale-up and technology transfer.
Robustness and reproducibility: Repeated confirmation runs verify process robustness, reproducibility, and operational stability, helping de-risk scale-up and ensure consistent production performance.
Integrated downstream process development: Upstream fermentation expertise is combined with downstream purification development, including cell harvest, disruption or extraction, clarification, chromatography optimization, impurity reduction, and product recovery.
Technology transfer and scale-up support: VALIDOGEN develops processes with industrial implementation in mind, providing robust, well-documented protocols and development data for transfer to your CDMO or manufacturing site.
Reduced cost of goods: By transforming an established E. coli or P. pastoris production strain into an industrially viable fermentation and purification process, VALIDOGEN helps improve process efficiency, consistency, and manufacturing economics.
Learn more about our microbial process development capabilities:
P. pastoris fermentation process development
E. coli fermentation process development
For projects requiring strain optimization prior to process development, we also offer tailored Pichia pastoris strain development based on our advanced UNLOCK PICHIA® platform.
Book a meeting to discuss your protein production process development project goals with our process experts.