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Icosagen is a mammalian protein drug discovery, development, and manufacturing expert, with uniquely combined CRO and CDMO capabilities under one roof, to offer fully integrated CRDMO services.
Icosagen built its own, 1400 m² GMP facility, that is equipped with state-of-the-art 50L, 200L and 1000L single-use bioreactors, along with GMP cell banking, seed train, upstream and downstream suites, as well as QC and QA to produce liquid GMP bulk drug substance.
Attaching it to our long-established R&D facility, our clients can now seamlessly transition their antibody and recombinant protein drug candidates from multi-parallel research concepts into preclinical stage, and EMA/FDA-approved phase I/II clinical trials.
Initial upstream process (USP) parameters for the IcoCell® lead clone are established during cell line development process in the Ambr®15 system. Key parameters including pH, dissolved oxygen and CO2, metabolite and nutrient levels are closely monitored.
Optimal USP parameters are finalized in the Ambr®250 system. Critical process parameters and conditions such as pH, dissolved oxygen, agitation feeding and gassing strategy are carefully adjusted, and resulting key metrics, including cell culture density and viability, product titers and desired quality attributes are optimized. With this scalable, multi-parallel single-use benchtop bioreactor platform, we establish optimal USP parameters for subsequent large-scale GMP manufacturing.
In downstream process development, an efficient purification process is established for the highly expressed drug substance, be it a platform-based antibody/Fc molecule or a de novo purification for a recombinant protein. Sequential chromatography and filtration steps, including virus removal/inactivation measures are combined to minimize impurities, downstream processing time and costs of goods, while optimizing product quality and yield.
Finally, confirmation runs in fully controlled bioreactors, in several liters scale, prove the establishment of a scalable, rapid, robust and efficient upstream and downstream process as foundation for 1000L scale clinical GMP material production.
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