has been approved by major regulatory authorities for the production of biopharmaceuticals and, on top of that, several appealing features render the UNLOCK Pichia platform
well suited for the production of biologics.
All components of VALIDOGEN´s Pichia toolbox, which has already been used to produce proteins for clinical studies, are thoroughly characterized and full documentation is readily available to support regulatory filings for your biologic candidate.
Reagents used at VALIDOGEN in the course of Pichia production strain development are certified animal-origin-free and strains generated at VALIDOGEN are genetically stable – a fundamental prerequisite for process consistency – due to the targeted integration of expression constructs into the host´s genome.
Unlike bacterial and mammalian production systems, Pichia produced recombinant proteins are not contaminated with either endotoxins or viruses, thus alleviating safety issues and further simplifying downstream processing in bioproduction.
Exceptionally high productivity, as is enabled by the broad and versatile VALIDOGEN Pichia toolbox, leads to a significant decrease of production costs.
In addition, one of the features of Pichia pastoris
is its ability to actively and effectively secrete a recombinant target protein into the culture supernatant with an exceptionally low amount of extracellular endogenous proteins. As a consequence, after simple cell removal recombinant protein from Pichia pastoris
can be obtained with purities of 70 - 80 % prior to purification. As compared to e.g. E. coli
, no cell lysis and tedious isolation from a usually very crude lysate or refolding from inclusion bodies is required to obtain the target protein.
Judging from numerous completed and ongoing development projects, protein production processes developed in VALIDOGEN´s labs have been shown to be robust and scalable facilitating sound technology transfer and straightforward implementation in large scale production facilities. Regardless whether you intend to transfer the manufacturing process to your facilities or to your CMO, our highly experienced team will support you in realizing a seamless process transfer.
VALIDOGEN's UNLOCK PICHIA technology for the production of glycosylated therapeutics
Pichia based protein production is no longer limited to non-glycosylated proteins. VALIDOGEN offers boosted glycoprotein production by combining VALIDOGEN´s Pichia technology with Pichia Glycoswitch®. Pichia Glycoswitch® enables the production of homogeneous and uniform glycoproteins with Man5- or other human-like glycoforms. The Picha GlycoSwitch® system is based on yeast strains that have been engineered to perform specific glycosylation steps at high fidelity.
Key benefits and technological features
- Approved for biologics production by regulatory authorities such as FDA and EMA
- Fully documented CMC compliant technology platform
- Animal-origin-free reagents and procedures
- Intrinsically endotoxin and virus free
- Glycoengineering tools for the production of tailor-made glycoproteins
- Reduced production costs due to high productivity
- Secretion of protein of interest enabling efficient purification processes
- Scalable, robust and economically viable production processes