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IcoCell is a proprietary platform to efficiently generate CHO-based stable high producer cell lines. These serve for large-scale GMP-compliant production of therapeutic recombinant proteins and monoclonal antibodies, both for clinical trial materials as well as for commercial production afterwards.
All stable IcoCell producer lines are characterized by exceptional productivities, comprehensive product characterization, short development timelines, assured monoclonality, and clonal stabilities. The business model is purely fee-for-service based, royalty-free, with full client cell line ownership.
Icosagen’s automated single-cell cloning cell line development workflow process combines single-cell printing with in-well droplet and whole-cell imaging. This ensures that every production cell line is a true mono-clone derived from a single progenitor cell. The VIPS (Verified In situ Plate Seeding) automatically captures and documents the journey from a single cell to colony outgrowth in a comprehensive clonality report. High-clarity images and accompanying data provide a unique ‘double lock’ of clonality assurance for IND submission.
As redundancy to generation VIPS-based clonality report, additional visual inspection of the images by two trained scientists increases the reliability that the cell line was derived from one single cell.
Step 1. Single-cell seeding evidence
Cells are imaged in multiple z-stack layers in the dry empty well before intelligence-based image analysis confirms the existence of a single cell. The well is then filled with medium.
Step 2. Clonal growth phase
During the clonal growth phase, VIPS performs daily high-clarity whole-well imaging, recording a timeline of well images and performing analysis to measure confluency. Successful clonal outgrowth can be traced back to a single cell to confirm monoclonality.
The “empty” CHO IcoCell is stably genetically modified with a regulatory accepted IcoCell transcriptional activator molecule sequence and passed a rigorous MCB biosafety testing procedure, to confirm e. g. the absence of any viral contamination.
For every newly created IcoCell CHO cell line, the entire gene for the encoded protein of interest is first optimized for maximal yield and product quality. During IcoCell cell line development, the transgeneäs DNA in the IcoCell expression vector is transfected into the “empty” starter cell and integrated into the CHO chromosome.
The robust, proprietary IcoCell technology fulfills two tasks. It facilitates the integration of the expression cassette into transcriptionally active regions of the CHO host cells’ chromatin, thereby ensuring the superior and lasting expression of the product. Secondly, the IcoCell transcriptional activator prevents the transgenes’ silencing during clonal cell line development and later industrial-scale commercial GMP manufacturing.
During the CLD-following upstream and downstream process development, the production conditions are further optimized e.g. for high viable cell densities, growth rates, metabolic parameters, as well as product quality and yields, specific to the protein product of interest.