Pichia Strain Development

Generation of high-performance protein expression strains

Time-saving generation of high-productivity strains with manufacturability in mind 


Effective bioprocess 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 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 strains and improve protein quality. We rapidly identify 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 strain 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.
 

Benefits

  • Accelerated generation of high-performance expression strains optimized for the production of commercial protein products
  • Enhancement of production levels & product quality
  • Fast and straightforward production of non-GMP protein samples
  • Reduced downstream processing efforts due to low levels of secreted impurities
  • Full documentation of UNLOCK PICHIA® toolbox elements to simplify and support your regulatory filings
     

Key features

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

     

Extended combinatorial screening

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 strain ready for scale-up.

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

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.

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.

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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