Transient feasibility production
Transient production is based on the BryoSpeed-technology. It allows for the fast availability of µg-amounts of high-quality, initial material. The standard timeframe comprises 10-12 weeks from customer-DNA to recombinant product.
The produced protein experiences complete post-translational modification and therefore serves perfectly for assessment of integrity and activity.
non-GMP production is based on the BryoMaster-technology.
A project typically starts with the arrival of customer DNA, followed by cloning and transfection steps. First high producing, non-optimised stable cell lines are available after four month and will produce g-amounts of non-GMP material in month six.
Production volumes depend on the target amount and vary from 5 to 300L batches.
Depending on project setup, the producer-clone can be further optimised in productivity and serve as a basis for the development of a GMP-compliant production process.
By means of homologous recombination, Physcomitrella-strains can be genetically optimised for the production of a specific customer protein. This may either be for achievement of a desired glyko-structure on the product, but can also be an enabling step like e.g. the elimination of a toxin target. Furthermore, any human enzyme, essential for post-translational processing of the product can be incorporated in the producing moss strain.
Generation of a knock-out or knock-in strain typically takes 4-5 month.
GMP cell-line and process development
Greenovation offers cell line- and process development to GMP standards for clinical evaluation and market production.
Based on the BryoMaster™-technology, stable producer clones are further optimised in productivity and a master cell-bank (MCB) is developed.
Following standard characterisations like e.g. genetic stability and product integrity a standardised process is
developed. The latter will be based on disposable wave-reactors (seed-train till production) and can finally be transferred in a GMP-environment for production.