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IcoCell Technology

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IcoCell Technology

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.  

IcoCell Cell Line Development Platform

STRONG & STABLE
EXPRESSION

STRONG & STABLE EXPRESSION

The IcoCell transcription-enhancing factor, together with cognate transcriptional DNA elements, engineered into any stable IcoCell cell line, ensures a strong and stable expression of the transgene. Also, this factor prevents transgene silencing during clone selection and later large-scale GMP production.

COMPREHENSIVE
ANALYTICS

COMPREHENSIVE ANALYTICS

The IcoCell cell line development path follows a rigorous analytical regimen with ever-increasing stringency on the product. cellular and manufacturability level.

GMP
DOCUMENTATION

GMP - COMPATIBLE DOCUMENTATION

Full documentation in form of a complete cell line development report is provided, which is essential for later regulatory submission and GMP manufacturing.

99.9%
MONOCLONAL
ASSURANCE

99.9% MONOCLONAL ASSURANCE

The VIPS™ Verified In-Situ Plate Seeding method allows one quick single cell cloning round, yet assuring 99.9% monoclonality.

EARLY POC
MATERIAL

EARLY POC MATERIAL

Our stable high producer clone pool approach yields grams-per-liter titers already weeks after CLD starts. These clone pools, together with our in-house DSP and analytical capabilities enable rapid assessment of early recombinant protein, e.g. in early in vivo studies. Analytical and formulation development as well as product stability studies can be started ahead of time.

CLONE
STABILITY

CLONE STABILITY

Any recombinant IcoCell CHO cell line is routinely tested to confirm being stable over at least 60 population doublings. This ensures constant product quality and yield from vial-cracking to several thousand-liter manufacturing scale.

We have designed the IcoCell technology platform such that our clients’ product candidates transition seamlessly from the discovery and lead candidates’ stage onto a clinical development path. From transient CHO production right into stable CHO high producer cell line development and in-house GMP manufacturing. For minimized risk and project management, yet maximized speed and quality. 

VIPS ‘Double Lock’ Monoclonality Assurance

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.
Technologies_VIPS_Double-Lock-Assurance

Science Behind IcoCell Technology

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.

Our locations

United States Office

77 Geary St. 5th Floor
San Francisco, CA 94108
+1 415 548 6625

European Office

Eerika tee 1
Õssu, Kambja vald
Tartu maakond 61713
Estonia
+372 737 7070
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