3d structure of a fusion protein

Pichia pastoris Protein Expression

Advanced Pichia pastoris strain and process development.

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Why companies choose VALIDOGEN for Pichia protein expression and process development

01 Proven at Scale: Up to 200,000 L

With more than 15 years of dedicated Pichia pastoris expertise, and hundreds of customer projects successfully completed, VALIDOGEN combines technology leadership with a proven track record of industrial implementation. Processes developed using our platform have been successfully transferred to GMP manufacturing at 100,000 L and industrial production volumes of up to 200,000 L, enabling reliable commercial manufacturing.

02 Up to 45 g/L Product Titers

VALIDOGEN has achieved recombinant protein titers of up to 45 g/L through targeted strain engineering, fermentation development, and process optimization. Leveraging more than 15 years of Pichia expertise, our team systematically optimizes cultivation conditions, fed-batch strategies, and induction protocols to maximize productivity, space-time yield, and manufacturing efficiency.

 

03 Up to 5-Fold Titer Improvement

Extensively validated platform protocols, refined through more than 15 years of dedicated Pichia expertise, provide a robust foundation for scalable, high-performance, and cost-efficient Pichia pastoris (Komagataella phaffii) fermentation. By systematically optimizing cultivation conditions, fed-batch feeding strategies, and induction parameters for each production strain, VALIDOGEN has achieved up to 5-fold titer improvements beyond already high-performing platform processes, maximizing productivity while reducing manufacturing costs.

04 Flexible Methanol-Free & Methanol-Induced Expression

VALIDOGEN's proprietary UNLOCK PICHIA® platform supports both methanol-free and methanol-induced Pichia fermentation, enabling the selection of the optimal expression strategy for each protein and manufacturing scenario. The platform combines validated host strains, expression tools, and process development expertise to maximize flexibility, productivity, and process robustness.

05 Tech-Transfer-Ready for Manufacturing

Every project is developed with industrial implementation in mind. VALIDOGEN delivers comprehensive technology transfer packages including process descriptions, development data, optimization rationale, and operating parameters required for efficient implementation by internal manufacturing teams or CMOs, supporting smooth GMP and non-GMP process transfer.

Working with VALIDOGEN

VALIDOGEN – 15 years of expertise in recombinant protein expression in Pichia pastoris
15+ years experience in Pichia protein expression

Pichia strain generation & optimization, plus process development for enhanced protein production 

UNLOCK PICHIA toolbox®

Broad and versatile protein expression technology platform for Pichia pastoris (Komagataella phaffii)

Customer-oriented services

Customized project setup in small, modular packages suitable for every industry

UNLOCK PICHIA® Protein Expression Technology and Services

Logo of UNLOCK PICHIA
01 Who We Are

We are a leading contract research & development organization specializing in recombinant protein expression using our exclusive UNLOCK PICHIA® protein expression technology. Our Pichia pastoris experts have been serving the protein production industry for more than 15 years.

02 What We Do

With our UNLOCK PICHIA® platform we apply a broad portfolio of technologies for successful and economically viable expression of your protein in the yeast Pichia pastoris (also known as Komagataella phaffii). 

We offer lean expression feasibility studies including delivery of purified lab-scale protein samples, generate high-performance Pichia production strains in competitive time frames, develop scalable bioreactor cultivation protocols, and undertake protein purification process optimization. Services are complemented with technology transfer for smooth implementation at your facility or with your CMO.

03 Our Technology

Protein production with UNLOCK PICHIA® 

Our expertise is paired with our exclusive UNLOCK PICHIA® technology toolbox, which consists of proprietary methanol-inducible and methanol-free promoters, platform strains, novel secretion signals, and expression-enhancing helper factors.

This toolbox allows for both methanol-induced and methanol-free expression systems, in addition to platform strains without the requirement for antimicrobial resistance genes (ARMs-free). Time-controlled target protein expression and co-expression of helper proteins allow for maximization of protein yields.

VALIDOGEN’s predictive high-throughput screening abilities and expertly developed protocols ensure fast and reliable identification of the best-performing genetic arrangement selected from thousands of Pichia strains assessed in parallel.
 

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Track Record

Icon symbolizing VALIDOGEN's contract research projects in recombinant protein expression
Contract Research Projects
  • Serving customers for more than 15 years
  • High-performance strains and processes developed for numerous industries and applications
  • Projects with clients ranging from small start-ups to industry giants

 

Icon representing VALIDOGEN's expertise in tech transfer and scale-up processes for industrial biotechnology.
Tech Transfer & Scale up
  • Efficient process transfer & scale-up to industrial scale (up to 200,000 L)
  • Phase I & II clinical studies performed with proteins produced using UNLOCK PICHIA®
  • Proteins produced by UNLOCK PICHIA® technologies on the market in different industry sectors
VALIDOGEN icon symbolizing strong intellectual property position in recombinant protein expression with Pichia pastoris
Intellectual Property
  • Firm IP position
  • Strengthening our technological leadership position
  • Continued R&D development generating new expertise and IP

Customer Testimonials

We used five companies before to produce our recombinant therapeutic, but they all failed. VALIDOGEN, with their PICHIA platform, was able to tweak the yeast to make the protein in a quantity high enough for our needs. Their expertise is outstanding in their ability to drive PICHIA to produce particular proteins, their proficiency in protein chemistry, and their excellent protein purification team. They proceed methodically, create comprehensive reports, and explain the results and the options they offer to reach the goal and deliver. They are a great team to work with.
CEO/CSO
BioPharma Startup - USA
The VALIDOGEN team has been a pleasure to work with and has played an important role in the success of our product development. Their technical expertise, flexibility, and proactive approach have made the process smooth and efficient. From project initiation to the CDMO transfer, they have been communicative and attentive to our needs, ensuring a tailored and effective collaboration. The UNLOCK PICHIA® platform has consistently delivered reliable results, and we’ve come to trust VALIDOGEN as a dependable partner. We look forward to continuing our partnership and would recommend their services to those seeking expertise in protein expression.
Founder and General Manager
BioPharma Startup - Germany
After an extensive review of leading CDMO working with Pichia pastoris we identified VALIDOGEN as the most skilled in this area. They effectively navigated us through the secretory pathways of Pichia and provided us with several high efficiency clones meeting all our COG’s target for the expression of our therapeutic protein. They are a pleasure to work with, very committed and delivered the project on time and on cost.
Chief Operating Officer
Medtech Company - UK

Discover VALIDOGEN

Scientist in lab coat inspecting stacked Petri dishes with blue medium, representing microbial screening for recombinant protein expression
Scientist in a VALIDOGEN lab coat operating a stainless steel downstream unit.
VALIDOGEN fermentation specialists working in a fermentation laboratory at VALIDOGEN.
Scientist in a VALIDOGEN lab coat reviewing bioprocess data on a tablet in front of a stainless steel fermentation system, with colleagues optimizing fermentation parameters in the background
2 downstream specialists working on protein purification in a laboratory
Fermentation development at VALIDOGEN
ALIDOGEN scientist evaluating Pichia pastoris colonies on agar plates

Contact us

VALIDOGEN's expert team is happy to discuss your project requirements. Send any project related requests to project@validogen.com, directly to our scientists, or use our contact form.
 

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