When you work with VALIDOGEN, you work with a team of experts with more than 15 years of experience in Pichia pastoris strain and process development. Our focus is delivering robust, high-performing strains and processes that accelerate your protein development success.
Unlike standard providers, everything we do is tailored to your project’s specific needs. By combining our UNLOCK PICHIA® platform with deep scientific expertise, we deliver customized solutions rather than one-size-fits-all services — ensuring the best chance of success for your protein. Our exclusive focus on Pichia pastoris further sets us apart, enabling us to apply unmatched depth of knowledge and optimization to every project.
Our services are valuable for a wide range of organizations:
Projects typically begin with a discussion of your protein(s) and goals, followed by a tailored proposal outlining possible strategies, timelines, and deliverables. We aim to make the onboarding process clear, collaborative, and efficient.
We optimize strains and processes for scalability, robustness, and reproducibility. A quick, low-cost feasibility study can also confirm early whether your protein will express successfully, helping to reduce risk before full-scale development.
Simply reach out to us via our contact page. We’ll set up an initial conversation to understand your needs and explore how we can help.
Feasibility studies provide a fast and cost-efficient way to check how well your protein can be expressed in Pichia pastoris. They allow you to obtain an early indication of success and a small sample for testing before committing to a larger development project. This reduces risk and supports informed decision-making at an early stage.
We create non-optimized stable strains using a few molecular tools from our UNLOCK PICHIA toolbox, test expression at microscale, and if needed, scale up to a 1 L bioreactor for a small protein sample, which can be purified if desired.
Feasibility studies are designed to be fast-track projects. Strain development can take as little as 4 weeks, followed by 2–5 weeks for cultivation and purification, depending on requirements.
We leverage our expertise and our proprietary UNLOCK PICHIA® toolbox of promoters, secretion signals, co-expression helper factors, and platform strains. By generating extensive genetic diversity and systematically screening for high-performing strains, we can identify optimal expression solutions for each individual protein.
Methanol-free Pichia pastoris strains are specifically engineered to achieve high-level protein expression without the need for methanol induction. The benefits include:
The choice depends on your protein, its intended application, or production site. For food, feed, or similar applications, methanol-free strains may be required.
In other cases, we recommend evaluating both methanol-induced and methanol-free systems, since performance can vary depending on the specific protein. Our team can design comparative development strategies to identify the best-performing option for your project.
Timelines vary depending on project scope and complexity:
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.
We apply a broad range of chromatographic and non-chromatographic purification methods depending on the target protein and its application. Chromatographic techniques typically include ion exchange, hydrophobic interaction, mixed mode, and affinity chromatography, often combined in multi-step strategies to achieve the desired purity and yield.
In addition to chromatography, we can apply diafiltration, ultrafiltration, precipitation, and extraction methods as part of the purification workflow. These approaches can simplify the process, reduce costs, or serve as preparatory steps before final chromatographic purification.
Purity levels depend on the protein and intended use. In most cases, our workflows achieve high-purity protein suitable for research and preclinical applications. For industrial enzymes, purification can be tailored to cost-effectiveness rather than maximum purity, while for therapeutic candidates, very high purity levels can be reached through optimized multi-step processes.
UNLOCK PICHIA® is VALIDOGEN’s proprietary platform, developed from decades of expertise in Pichia. It stands out because it combines a broad toolbox of genetic elements (promoters, secretion signals, co-expression factors, platform strains) with high-throughput screening and systematic optimization strategies. This enables rapid identification of top-performing strains tailored to each protein’s requirements.
Yes. UNLOCK PICHIA® includes methanol-free expression systems, eliminating the need for methanol induction. This makes it suitable for sensitive industries such as food & feed, and agriculture, or working at large scale, while maintaining high expression levels.
It stands out because it combines a broad toolbox of genetic elements (promoters, secretion signals, co-expression factors, platform strains) with high-throughput screening and systematic optimization strategies. This enables rapid identification of top-performing strains tailored to each protein’s requirements.
Yes. Through glyco-engineered strains, we can modify the glycosylation pattern of proteins expressed in Pichia pastoris, allowing production of proteins with human-like N-glycosylation, where potential immunogenicity of the product is a concern.
Optimization is achieved by systematically combining different promoters, secretion signals, helper factors, and strain backgrounds to generate genetic diversity. High-throughput screening then identifies strains with superior expression, secretion, and product quality, leading to significantly higher protein yields.
Genetic modifications are typically introduced via molecular cloning and targeted integration of expression cassettes designed to work efficiently in Pichia.
Pichia pastoris is a proven production host that delivers high yields at low cost. It grows on simple media, reaches very high biomass, and can be scaled easily from lab to industrial fermenters. With secretion capability and eukaryotic folding machinery, it bridges the gap between bacterial and mammalian systems.
Compared to mammalian cell lines, Pichia offers:
Unlike E. coli, Pichia is a eukaryote and can:
No. While traditional Pichia expression systems use methanol-inducible promoters, methanol-free systems are also available. These eliminate the need for methanol handling and are especially useful in regulated industries such as food & feed, and agriculture, or when working at large scale.
Yes. Pichia has been used to manufacture of approved biopharmaceutical products and is recognized as a reliable and scalable production host. The clinical pipeline shows that it is an attractive host for diverse protein formats such as domain antibodies. It is particularly attractive for biologics requiring high yields and cost-effective production.
Yes. Pichia pastoris has obtained GRAS (Generally Recognized as Safe) status for many applications, and is on the EFSA QPS (Qualified Presumption of Safety) list. It is widely considered a safe microbial host for production in the food and feed industries. For some feed applications the supernatant is pure enough that it can be used directly with no downstream processing.
Pichia is used across industries to produce a wide range of proteins, including antibody fragments (e.g. vHHs/nanobodies), vaccine antigens, serum proteins, therapeutic enzymes, and industrial enzymes. This versatility makes it a go-to system for applications in healthcare, biotechnology, food, feed, and industrial bioprocesses.
