Transferable Pichia pastoris cultivation processes - developed with manufacturability in mind
At VALIDOGEN, early-stage bioprocess development ensures that your protein production process is robust and scalable. By aligning process design with manufacturing needs we reduce risks, optimize cultivation, and streamline technology transfer - setting the stage for efficient scale-up and reliable commercial production.
At VALIDOGEN, we specialize in developing robust, scalable, and high-yield Pichia pastoris fermentation processes that perform reliably from lab to production scale. Starting from our established platform protocols, our fermentation experts design and optimize production processes tailored to your target protein and application. From the earliest development stages, scale-up and regulatory considerations are embedded into each project to ensure that results obtained at laboratory scale translate seamlessly to pilot and industrial production. This minimizes adaptation during technology transfer and enables smooth, cost-efficient implementation at large scale.
Customers worldwide have successfully established VALIDOGEN-developed Pichia pastoris processes at volumes of up to 100,000 L, confirming the robustness, scalability, and transferability of our UNLOCK PICHIA® technology.
Whether your goal is to produce a therapeutic protein, industrial enzyme, food or feed ingredient, or diagnostic protein, VALIDOGEN delivers reliable processes designed for consistent quality, efficiency, and commercial viability. With over 15 years of expertise VALIDOGEN enables clients to move confidently from early development to full-scale manufacturing - avoiding costly setbacks and securing long-term production success.
Our team of experienced Pichia specialists brings over 15 years of hands-on fermentation expertise. We rapidly translate lab-scale insights into optimized processes, shortening development timelines and reducing risks during scale-up and commercial manufacturing.
By combining methanol-induced or methanol-free expression systems with our bioprocess expertise, we deliver high-productivity protein production processes that are both robust and scalable. The methanol-free production technology is adaptable to different cultivation strategies, including short cultivations to enable process intensification, and optimized cultivations in VALIDOGEN standard time to maximize product titers.
Our process development program ensures process robustness and reproducibility from the earliest stages. Stable, well-characterized processes minimize variability and reduce risks during scale-up.
VALIDOGEN’s Pichia fermentation processes scale seamlessly from lab to industrial production, maintaining yield and quality across all volumes. Proven scalability up to 100,000 L ensures a smooth transition into pilot and commercial manufacturing. We deliver complete process documentation, validated data packages, and expert tech transfer support - ensuring seamless scale-up and confident implementation in GMP or non-GMP environments.
Our team of experienced Pichia specialists brings over 15 years of hands-on fermentation expertise. We rapidly translate lab-scale insights into optimized processes, shortening development timelines and reducing risks during scale-up and commercial manufacturing.
By combining methanol-induced or methanol-free expression systems with our bioprocess expertise, we deliver high-productivity protein production processes that are both robust and scalable. The methanol-free production technology is adaptable to different cultivation strategies, including short cultivations to enable process intensification, and optimized cultivations in VALIDOGEN standard time to maximize product titers.
Our process development program ensures process robustness and reproducibility from the earliest stages. Stable, well-characterized processes minimize variability and reduce risks during scale-up.
VALIDOGEN’s Pichia fermentation processes scale seamlessly from lab to industrial production, maintaining yield and quality across all volumes. Proven scalability up to 100,000 L ensures a smooth transition into pilot and commercial manufacturing. We deliver complete process documentation, validated data packages, and expert tech transfer support - ensuring seamless scale-up and confident implementation in GMP or non-GMP environments.
Process development projects at VALIDOGEN begin by using our extensively validated platform protocols, a solid foundation for developing high-performance, scalable, and economically viable processes for your specific protein and application. This can be carried out using strains we have developed for you or any Pichia pastoris strain - whether it originates from your laboratory or a third-party source.
Depending on your project needs, our experts can focus on fermentation process optimization for your production strain, characterizing its growth and expression profile. We apply a systematic and data-driven workflow to fine-tune media composition, feeding strategy, and induction parameters, maximizing performance, productivity, and process robustness. Our suite of parallel bioreactors and microbioreactor systems enables rapid iteration and cost-efficient optimization, ensuring an accelerated and tailored process development.
From targeted parameter adjustments to full Design of Experiments (DoE) campaigns, we create fit-for-purpose fermentation processes designed for manufacturability, robustness, and scalability.
Our platform protocols provide reliable starting conditions and are designed to suit most Pichia pastoris strains.
This initial stage, performed in our 1L and 10 L bioreactors, delivers solid fermentation performance and enables rapid production of protein samples for early-stage evaluation and analysis.
VALIDOGEN’s experts apply customized process optimization to fine-tune cultivation parameters, including media composition, feeding regimes, and induction strategy, for your target protein. This approach maximizes productivity, yield, and quality. Depending on project requirements and objectives we can conduct process optimization ranging from targeted, one-parameter-at-a-time studies to comprehensive Design of Experiments (DoE) strategies, ensuring the optimal balance between experimental depth, efficiency, and outcome.
To ensure consistency and reliability, we conduct multiple confirmation runs to verify process stability and reproducibility.
Processes at VALIDOGEN are designed for seamless scale-up and GMP readiness. This allows for smooth translation to pilot and industrial scale with minimal modifications, reducing risks during technology transfer and commercial implementation.
When you’re ready to scale, VALIDOGEN provides comprehensive tech transfer support, including detailed development reports, optimization data, and the rationale for final process design.
Our experts can assist with process scale-up at your facility or your CMO’s site, either remotely or in person. We support your team during initial production runs, help adjust parameters for larger bioreactors, and troubleshoot challenges, ensuring smooth and reliable process implementation.
To complement upstream fermentation, VALIDOGEN offers comprehensive protein purification process development.
In close collaboration with our customers, we optimize chromatography steps, determine binding capacities, and maximize yield and purity while ensuring efficient impurity clearance.
This integrated upstream and downstream development approach enables high-quality, scalable, and cost-efficient protein production across all applications and industry sectors.
Early development enables you to optimize strain performance and fermentation conditions before moving into scale up, or expensive GMP environments. This approach reduces risk, and ensures a smoother, more cost-efficient transition into manufacturing.
Yes. Even if the strain was developed elsewhere, we can apply our expertise in Pichia fermentation to optimize expression levels, productivity, and process robustness. This often results in significantly higher yields and lower costs compared to unoptimized processes.
Yes. Our development is always performed with scalability in mind. Processes optimized in our labs are designed to transfer smoothly to industrial fermentation facilities, maintaining productivity and product quality at large scale.
We develop processes at scales up to 10 L bioreactors. VALIDOGEN is not a GMP facility — instead, we deliver tech-transfer-ready processes that can be handed over to your selected CDMO for GMP manufacturing. We have undertaken many such transfers.
A tech-transfer-ready process is one that has been well characterized and optimized, with robust fermentation conditions, reproducible performance, and thorough documentation. This ensures that a CDMO can implement the process at larger scale without additional major development steps.
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.
