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Stable CHO Cell Line Development Service — IcoCell

The stable CHO cell line development platform IcoCell generates biopharmaceutical high-producer clones in CHO cells, with competitive titers and timelines, and robust, predictive large-scale manufacturing properties for therapeutic proteins and antibodies. Stable CHO cell line development is seamlessly connected to our integrated in-house discovery and development capabilities, as well as our comprehensive analytical and downstream processing expertise.

Icosagen’s uniquely combined discovery, development, and manufacturing capabilities effectively accelerate our clients’ pre-clinical and clinical development timelines, de-risk their projects, and thus greatly saving costs and project management efforts.

Stable CHO Cell Line Development Service_Icosagen CRDMO_Reactor

WE
PROVIDE
SOLUTIONS

WE PROVIDE SOLUTIONS

In the last 25 years, Icosagen has produced thousands of purified antibodies and proteins from CHO&HEK cells. Over 3000 of them in 2023 alone, for more than 100 biotech and pharma companies. With this comes our vast experience in essentially all formats of antibodies and proteins, different frameworks, species and Fc-effector functions, bi- and multi-specifics, and all sorts of recombinant proteins. Come and tap into our expertise on function and manufacturability assessment of your molecules.

PROJECT
MANAGEMENT

PROJECT
MANAGEMENT

Every stable CHO cell line development project will be accompanied by its own dedicated project manager, as a reliable and constant point of interaction. Icosagen has a reputation for rapid, transparent, and knowledgeable communication and our clients highly value remaining closely involved in their projects’ progress and success.

CLONE
STABILITY

CLONE STABILITY

Any recombinant IcoCell CHO cell line is routinely confirmed being genomically stable. This is achieved through the proprietary IcoCell-specific semi-directed transgene integration into the open chromatin and the careful antibiotics-free selection regimen. This effect of assured genomic stability is that a cell line maintains from vial-cracking to commercial 20 000L bioreactor production runs a constantly high product quality and productivity.

Stable CHO Cell Line Development Workflow with IcoCell

Early Stage of Optimized CHO Cell Line Development
At the first stage, our optimized CHO cell line development process yields stable producer clone pools, with robust, unoptimized fed-batch productivities of several grams per liter, already weeks after transfection. 

Development and Confirmation of High-Performing Monoclonal Cell Lines
The high producer clone pools are then carefully developed into high-performing monoclonal cell lines, which are confirmed for product quality, genetic stability, and large-scale bioreactor manufacturing fitness. Additional purified material can be quickly produced at any time, to re-confirm product characteristics and to support any parallel in vitro or in vitro activities.  

Early Multi-Parallel CHO Production with QMCF Platform
Even prior to stable CHO cell line development, our proprietary, in-house QMCF transient expression platform enables the early multi-parallel CHO production of grams scale-purified antibodies and proteins. This serves to start crucial initial exploratory activities such as analytical development, downstream processing, formulation, and initial in vivo POC experiments.

Icosagen's CRDMO Concept - One Site. One Team. One Project. Saving Time, Costs, and Nerves. 
With this head start on molecule know-how, with legal agreements in place, with trusted project teams already firmly established, Icosagen’s seamless CRDMO concept from transient R&D mgs to stable clone pools and cell lines saves easily several months of time by eliminating any CRO-to-CDMO tech transfer. On top of it, it preserves precious molecule know-how and project management efforts, thus saving time, costs, and nerves. 

 

Stable CHO Cell Line Development Service — IcoCell

Why choose IcoCell for GMP compatible stable cell line development?

HIGH
PRODUCTIVITY

HIGH PRODUCTIVITY

Our CHO cell line development workflow yields stable biopharmaceutical cell lines with production titers up to 10 g/L for recombinant antibodies and proteins. It's based on a proprietary, biosafety-tested CHO-S starter cell line equipped with a regulatory approved viral transcriptional enhancer. This ensures controlled, strong, and lasting protein expression levels through semi-directed stable integration into active chromatin. Prior to full process development, we assess performance in the ambr®15 system.

RAPID
TIMELINES

RAPID TIMELINES

At the first stage, our optimized CHO cell line development process yields stable producer clone pools, with robust unoptimized fed-batch productivities of several grams per liter, already weeks after transfection.

PURE FEE
FOR SERVICE

PURE FEE FOR SERVICE

The IcoCell stable CHO cell line development platform as well as later development and manufacturing platforms are license-free, purely fee-for-service based, free of milestone payments and any royalties.

99.9%
MONOCLONAL
ASSURANCE

99.9%
MONOCLONAL
ASSURANCE

In our IcoCell platform we employ the VIPS™ (Verified In-Situ Plate Seeding) Technology to assure 99.9% monoclonality. The "double lock" method combines post cell-dispensing imaging and analysis with daily outgrowth imaging for later regulatory submission.

FULL
REGULATORY
DOCUMENTATION

FULL
REGULATORY
DOCUMENTATION

Full documentation will be provided as a cell line development report, on starter cell history, all handling and reagents used, etc., which is essential for later regulatory submissions and GMP manufacturing.

COMPREHENSIVE
ANALYTICS

COMPREHENSIVE ANALYTICS

The IcoCell stable cell line development platform follows a rigorous analytical regimen with ever-increasing stringency along the way, both on the cellular parameters, as well as on product characteristics, to predictably generate industrial high-performance CHO production stable cell lines.

Early Stable Cell Line Development and Non-Clinical Protein Production

Early Assessment of Clinical Candidates with Rapid and Affordable Stable Clone Pool Approach

Icosagen offers a rapid and affordable stable clone pool approach for those interested in obtaining an early glimpse of their future clinical recombinant protein or antibody. The stable clone pools stage provides high titers at a gram per liter scale, making it an ideal predictor of later clonal cell line productivity. This stage enables the production of grams to even hundreds of grams of near-clinical material, facilitating in vitro or in vivo proof-of-concept (POC) studies and allowing for the assessment of candidate characteristics before full GMP production. The benefits of this approach include the ability to de-risk a full development program, progress incrementally in terms of finances and effort, and re-confirm previously generated results using near-clinical material. Additionally, this early material assessment can be conducted in parallel for multiple molecules, resulting in a significant time-saving of four months in development.

Completing Crucial Activities Alongside Stable Clone Pool Stage

The stable clone pool stage serves as the initial comprehensive stage in the stable clonal CHO cell line development program offered by Icosagen. While awaiting the clone pool-derived data, other crucial activities can be carried out concurrently. These activities encompass analytical and formulation development, downstream processing, stability studies, and more. By progressing with these essential tasks in parallel, valuable time is saved, and the overall development process becomes more efficient and streamlined. This approach allows for maximum utilization of resources and ensures a comprehensive and well-rounded development program for future clinical recombinant protein or antibody candidates.

EARLY
PROOF OF
CONCEPT

EARLY PROOF OF CONCEPT

Stable producer clone pool titers convey a robust indication of the expected productivities of the final clones, and allow e.g. early proof of concept in vivo in non-GLP toxicology studies, to re-confirm the clinical candidates' potential.

INITIAL
UPSTREAM
PROCESS
DEVELOPMENT

INITIAL UPSTREAM PROCESS DEVELOPMENT

IcoCell minipools can be used to produce material for early proof of concept and non-GLP tox studies. Also for IVD assays.

PURE FEE
FOR SERVICE

PURE FEE FOR SERVICE

The IcoCell stable CHO cell line development platform as well as later development and manufacturing platforms are license-free, purely fee-for-service based, free of milestone payments and any royalties.

PARALLEL
CANDIDATE
ASSESSMENT

PARALLEL CANDIDATE ASSESSMENT

Save 4 months in development time by conducting early material assessment in parallel for multiple molecules, focusing solely on the best candidate for further progress.

PROJECT
DE-RISKING

PROJECT DE-RISKING

Early material from stable producer clone pools is the first stage at which one can obtain tangible purified recombinant material that allows an initial peek on the later clone-derived protein. This material can be tested for activity in vitro and even in vivo, and several project-accelerating activities (such as analytical and formulation development) can be started ahead of time.
Stable CHO Cell Line Development Service_Icosaen CRDMO_Dr.Oliver Schub portrait

For inquiries about custom CHO cell line development service, contact Dr. Oliver Schub

IcoCell workflow for stable high producer clone pool production

Stable CHO Cell Line Development Service — IcoCell
Antibody
discovery
Antibody
development
Protein
production
Analytics

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