Pichia Pastoris Strain Development

Generation of Pichia protein expression strains for commercial protein production

Strain engineering service for Pichia pastoris (Komagataella phaffii)

With over 15 years of experience in Pichia strain development, and implementation of our cutting-edge UNLOCK PICHIA® technology platform, we offer an unparalleled combination of know-how and technology to fast-track your protein expression project. By combining rational strain design with process optimization, VALIDOGEN transforms Pichia pastoris into a precision tool for recombinant protein production.

High-performance strain engineering for Pichia pastoris

With manufacturability in mind

Effective process development starts with the targeted and time-saving generation of high-productivity strains, taking into account your economic target values and regulatory requirements from an early stage. The UNLOCK PICHIA® technology platform comprises a large number of versatile expression tools for the generation of effective industrial Pichia protein production strains without compromising development timelines.

VALIDOGEN’s UNLOCK PICHIA® platform boosts the methanol-induced or methanol-free expression of your protein by comparing thousands of combinations of different promoter variants, strain backgrounds, helper factors, and secretion signals. Our unparalleled spectrum of expression tools and ingenious expression strategies function together to generate high-performance Pichia strains and improve protein quality. We rapidly identify Pichia production strains secreting your protein with highest product yields by applying a combinatorial microscale cultivation & screening regime.

All aspects of manufacturability from targeted debottlenecking to product quality (including glycosylation issues) and regulatory requirements (antibiotic-free strain selection), as well as process safety (methanol-free production) and process economy are considered and integrated at the earliest possible stage during Pichia strain/cell line development. We then further unlock Pichia's potential by applying robust and highly proven cultivation protocols through VALIDOGEN's expert process development and optimization program.

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Key benefits of VALIDOGEN's Pichia pastoris strain development service

01 Unparalleled Pichia Platform & Expertise

UNLOCK PICHIA® Technology

We harness our exclusive Pichia pastoris engineering platform to create robust, high-performing production strains designed to meet commercial manufacturing requirements. This advanced toolbox includes a proprietary library of strong and tunable promoters (methanol-induced and methanol-free), synthetic secretion signals, co-expression helper factors, and host strains that collectively drive exceptional expression performance.

Deep Strain Engineering Know-How

With over 15 years of dedicated Pichia R&D, our team has unmatched expertise in yeast strain development. We combine cutting-edge science with experience-driven insights, ensuring your project benefits from both advanced technology and skilled Pichia specialists. 

02 High Productivity & Efficient Timeframe

Superior Yields

Get boosted protein yields with our optimized strains while maintaining product quality. Higher titers translate to lower production costs and more efficient manufacturing, giving you a cost-effective path to scale.

Effective Strain Development Cycle

By leveraging our broad range of UNLOCK PICHIA® platform tools we deliver strains targeted to your protein expression needs. High-throughput screening allows us to identify top performing clones in an efficient timeframe, streamlining your progression to commercial manufacturing.
 

03 Flexible Expression Systems & Safety

Methanol-Induced or Methanol-Free Pichia Strains

We offer highly efficient methanol-induced promoters along with methanol-free variants and protocols, allowing you to choose the expression system that best suits your product and regulatory environment.

ARMs-Free Strains (No Antibiotic Markers) 

For applications such as food and feed, where there may be regulatory constraints, we can provide platform strains completely free of antibiotic resistance markers (ARMs-free). 
 

04 Quality Compliance & Regulatory Readiness

CMC-Ready Strain Development

Our UNLOCK PICHIA® strain development program is executed with Chemistry, Manufacturing and Controls (CMC) requirements in mind. From the earliest stage, we optimize for robustness, consistency, and scalability. The result is a strain and process suited for GMP manufacturing, de-risking your move towards clinical or commercial production.

Regulatory Support & Documentation 

Strains we deliver are supported with full documentation of genetic constructs and development history, streamlining your regulatory submissions. 

Our Pichia strain development process

Extended combinatorial screening of clones

Access the full offerings of our UNLOCK PICHIA® toolbox with a fast and reliable extended screening assessing thousands of clones. Let us identify the optimal genetic combination of novel strain, promoter, and secretion signal, and additionally evaluate our helper factor suite to generate a high-performance Pichia cell line ready for scale-up.

Deep-well plates with scientists in the background working on a laminar flow hood
Scientist using microbioreactor technology in Pichia strain development.

Microbioreactor Cultivation

Capable of monitoring and controlling temperature, pH value, level of dissolved oxygen, and feed rate, our 1 mL well microscale cultivation device is the perfect step between a shaken screening system and a bioreactor.  Using this system, the performance of different Pichia strains can be assessed using an identical protocol, or the effect of selected upstream process parameters on protein production can be evaluated.

Bioreactor Cultivation

1 L and 10 L bioreactors are used to confirm the productivity levels of top-performing Pichia clones, and to generate material for purification. Our fermentation specialists have developed highly transferable and scalable protocols for both methanol-induced and methanol-free protein production processes.

VALIDOGEN fermentation specialists working in a fermentation laboratory at VALIDOGEN.
2 downstream specialists working on protein purification in a laboratory

Protein purification

Our DSP scientists can develop an initial protein purification protocol to provide you with a non-GMP sample in a buffer of your choice. According to your requirements, we will also take downstream processing one step further providing full protein purification process development for a robust scalable process. 

Cell Banking

We provide high-quality glycerol preparations to ensure the integrity of your Pichia cell line. Cell line characterization includes purity check, viability check, assessment of the integration of expression cassette(s), whole genome sequencing, and copy number determination.

Gloved hands holding a cryobox with frozen sample vials in front of a frosted freezer wall; one vial is being retrieved

Key features

UNLOCK PICHIA® strain engineering platform & service

Technology
  • Methanol-induced or methanol-free processes
  • Option for antimicrobial resistance marker-free (ARMs-free) strains
  • Large combinatorial screening of several thousand clones evaluating a diverse set of novel promoters, secretion signals, and expression strains
  • Helper factor co-expression for enhancement of protein production
  • Reliable & uniform microscale cultivation and predictive HT screening for identification of high-productivity clones
  • Microbioreactor system to aid comparative strain evaluation
  • Cultivation of most productive clones in 1 L or 10 L bioreactors for rapid protein production
     

 

Deliverables
  • High-performance expression strains as glycerol stocks
  • Characterized research cell bank
  • Protein in cell-free culture supernatant or as purified sample
  • Comprehensive report
  • Support from our experts regarding project results and next steps

     

OUR TEAM OF EXPERTS

Contact us to learn more about VALIDOGEN’s service portfolio

Iskandar Dib, PhD
Principal Scientist & Business Development Manager
Rosie Maddock, PhD
Business Development Manager

Contact our Pichia pastoris experts to discuss your strain development project and find the right solution. Send any project related request to project@validogen.com, directly to our scientists, or use our contact form.

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