Cell Line Development Using CHOFlow®
Core Expression Platform for ADCC enhanced Antibodies and Beyond
Critical quality attribute (CQA) as physical, chemical or biological characteristics ensure desired product quality, safety and efficacy of biopharmaceuticals. N-glycans are typical CQAs which can influence biological activity as well as serum half-life in the human body. The core fucosylation of monoclonal antibody (mAb) Fc N-glycans can be considered as an outstanding CQA as it directly affects the affinity of the mAb to the FcγRIIIa receptor on NK cells and thereby is directly influencing biological activity through immune effector functions. A reduction of core fucose increases the binding to the FcγRIIIa receptor and thereby enhances the antibody dependent cellular cytotoxicity (ADCC) which is a primary mechanism of action (MoA) in immunotherapy.
CHOFlow® is our own glycoengineered cell line for afucosylated mAbs and other biopharmaceuticals.
Fucose Matters: CHO Stable Cell Line Development for Enhanced ADCC
With FyoniBio´s innovative CHO expression system CHOFlow® mAbs carrying afucosylated N-glycans on mAbs and other biopharmaceuticals can be realized while maintaining high productivities and product qualities.
CHOFlow® unifies excellent productivity rates (> 5 g/L) and exceptionally stable and robust production processes of our CHOnamite® host cell line with a proven genetic FUT8 knock-out (KO) glyco-optimization strategy. This allows FyoniBio to develop cell lines that produce our customer’s mAb candidates with enhanced ADCC effector function to significantly improve the therapeutic efficacy of the mAbs.
The core fucosylation of mAbs can be considered as a prominent critical quality attribute (CQA) as it directly affects the affinity of the mAb to the FcγRIIIa receptor on natural killer cells and thus is influencing the biological activity through immune effector functions. A reduction of mAb’s core fucose directly increases binding affinity to the FcγRIIIa receptor and thereby enhancing the ADCC activity leading to increased killing of target cells.
CHOFlow®: Our Solution for Stable and Reliable Production of afucosylated Glycoproteins
CHOFlow®, our unique glycoengineered cell line enables production of afucosylated biopharmaceuticals in robust and reliable production processes.
Explore the Manifold Advantages of CHOFlow®:
- Excellent productivity of > 5 g/L in our standard fed-batch process
- Proven robust stability over more than 70 population doublings to meet GMP requirements
- mAb N-glycans lacking core fucose while the other N-glycan structures are not affected
CHOFlow® Improves FcyRIIIa Binding and mAb Potency
- Significantly improved ADCC due to enhanced binding affinity to FcγRIIIa by factor 10
- Increased potency and therapeutic efficacy
- Especially suited for low receptor density target cells and the low affinity variant of the FcγRIIIa (F variant)
- Allows the reduction of treatment dosage requirements at maintaining the therapeutic effect
Need more information about our ADCC enhanced cell line development services using the CHOFlow cell line platform?
Frequently Asked Questions (FAQ) for CHOFlow® Cell Line Development Services
Each project is unique. We can certainly tailor our services to your specific needs. Each individual project is planned to meet the customer’s specifications, costs and time lines. The project plan, consisting of one or more working packages, has a flexible design and can be discussed and adapted, if desired. Get in touch with us and discuss the specific requirements of your project.
Cell Line Development Services – Related Content
Learn more about the CHOnamite® platform for the robust production of biotherapeutics.
Learn more about the human GlycoExpress® platform.
Explore how the potential of your biotherapeutic can be evaluated across multiple cell line platforms in our customized feasibility study.
Cell Line Development Services – Downloads
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Feasibility Study Flyer