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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.
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.
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.
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