Protein expression feasibility studies

Speedy determination of protein expression potential in Pichia pastoris

Determination of expression potential and rapid production of protein samples

Let us elucidate the expression potential of your protein in a quick feasibility study. Starting from an optimized DNA fragment we will clone, transform, and screen for expression in Pichia for a reliable go/no-go decision within a few weeks. In a targeted and concise approach we evaluate different molecular tools to find the optimum combination of genetic elements for your protein. Building on these factors, a highly efficient production strain can then be developed in a comprehensive strain development program by fully applying VALIDOGEN’s UNLOCK PICHIA® toolbox.

Positive strains can be directly transferred to a bioreactor cultivation enabling the production of initial protein samples. To provide you with a highly pure sample of your protein in a short time we will set up a purification process based on standard chromatography techniques, yielding milligram to gram quantities of pure protein from a Pichia culture supernatant.

Benefits

  • Fast assessment of expression feasibility and potential for further improvement
  • Immediate answers for a reliable go/no-go decision
  • Results from microscale screening transferable to bioreactor cultivation
  • Rapid generation of protein production strains and purified protein samples
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Key features

Technology
  • Methanol-induced or methanol-free processes
  • Unique promoters and novel secretion signals
  • Helper factor co-expression
  • Option for antimicrobial resistance marker-free (ARMs-free) strains 
  • Reliable & uniform microscale cultivation and predictive HT screening
  • Microbioreactor system to aid comparative strain evaluation
  • Cultivation of most productive clones in 1 L or 10 L bioreactors for rapid protein production
  • Fast set-up of a standard protein purification protocol
Deliverables
  • Expression strains as glycerol stocks
  • Crude or purified protein samples (non-GMP)
  • Comprehensive report 
  • Discussion with our experts covering results and next steps

UNLOCK PICHIA® Expression Feasibility Tools & Workflow

Expression Screening

Our predictive high-throughput screening system quickly and effectively evaluates the expression potential of your protein. Customizable screening parameters allow for the assessment of UNLOCK PICHIA tools as desired.

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 strains can be assessed using an identical protocol, or the effect of selected upstream process parameters on protein production can be evaluated.
 

Bioreactor Cultivation

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

FAQs - Protein expression feasibility studies

How do feasibility studies in Pichia support a go/no-go decision?

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.

What does a Pichia protein expression feasibility study involve?

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.

Who should do an expression feasibility study?

  • Companies in late lead-finding stages, wanting to evaluate several protein candidates in parallel.
  • Organizations seeking manufacturability assessment, before investing in a full program.
  • Early-stage companies or startups needing proof-of-concept samples to secure funding or move to the next milestone.

What is a typical timeline for a feasibility study?

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.

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

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.

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