Cell Line Development
Identify the matching host cell line for your biotherapeutic
Cell line development is one of the most important steps for establishing a biopharmaceutical manufacturing process. Starting from the evaluation of fitting DNA vector constructs up to the selection of top production clones, a well-designed cell line development strategy is required to obtain the best solutions for GMP production. Optimum productivity and bioactivity is not always achieved with one single cell host as product quality attributes may differ widely from one biotherapeutic to another. Therefore, finding a suitable expression host is critical to support desired product characteristics.
Benefit from FyoniBio’s Fast Track Cell Line Development Services
Acceleration of cell line development technology is the key for a cost-efficient development of a biopharmaceutical manufacturing process. At FyoniBio we combine highly producing cell lines and customized expression vectors which are incorporated into pool and minipool selection procedures. Thereby we increase the probability of identifying high producer clones. To verify protein quality early on, direct integration of PTM/ glycan analytics into cell line development procedures is possible – in-house and with fast turnaround time.
In our cell line development, single cell cloning uses 3-4 highest producing (mini)-pools bringing forth clones with varying characteristics. Multiple rounds of clone screening are performed starting with initial 96-well screening up to bioprocess integrated screening in batch, fed-batch and perfusion mode. For this purpose, we use suitable down-scale models to directly find a process fitting monoclonal cell line.
Stability testing and the possibility for early USP optimization complete the cell line development procedure and enable direct transfer to a GMP manufacturer.
Cell Expression Platforms for Custom-Tailored Cell Line Development
FyoniBio provides custom-tailored cell line development services using its expression platforms GlycoExpress® and CHOnamite® to find the most suitable host cell line.
Cell Line Development Services using GlycoExpress®
GlycoExpress® (GEX®) is a screening and high yield production platform of proprietary glyco-optimized human cell lines for development and production of biotherapeutics with authentic human PTMs (e.g., glycosylation). GEX® enables high quality expression of difficult-to-express glycoproteins.
Learn more about the the GlycoExpress® platform.
Cell Line Development Services using CHOnamite®
CHOnamite® is an in-house developed CHO platform originating from CHO-K1 and CHO-DG44 cells. This cell line solution enables high yield production of antibodies, complex mammalian proteins and can be used to find the right solution for biosimilar development. Find best matching quality attributes by double tracking in our multiple cell line platforms.
Cell Line Characteristics and Selection Criteria
- “Dual cell line” platform originating from CHO-K1 and CHO-DG44 cell lines
- High-yield production in fed-batch processes
- Strategies for product specific glyco-optimization available
- Expression of standard antibodies, biosimilars and complex mammalian proteins
- Genuine human glycosylation and further PTMs
- High productivity for glyco-optimized products
- Toolbox of glycoengineered cell lines: adjustment of sialylation, fucosylation, and mannose-6-phosphate
- Established expression platform for difficult-to express, defucosylated and complex glycoproteins
Key Features of Cell Line Development at FyoniBio
Our state-of-the-art cell line development is carried out to find highly productive cell clones with excellent quality parameters. With a customized feasibility study you can compare your protein in both GEX® and CHOnamite® cell lines at a low cost. Flexible, royalty-free licensing models are provided.
- Robust and scalable systems
- Tech transfer to GMP manufacturer of your choice
- Flexible commercial licensing
- Fully traceable documentation is provided for all cell line development projects to fulfill EMA and FDA requirements.
Obtain Reliably, High Producing, Glyco-optimized and Stable Cell Lines
CHOnamite® cell lines in combination with fed-batch enable high yield productivity around 4-8 g/L for classical IgG1 molecules. A combination of clone screening with media testing results in selection of the best process conditions for high yield production.
Glyco-optimized GEX® cell lines are optimized for perfusion processes which are characterized by high reproducibility, scalability and product quality.
Need more information about our cell line development services?
Frequently Asked Questions (FAQ) for 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.
While CHO cells often show remarkable productivities, some proteins simply don’t seem to work in this rodent system. We showed that difficult-to-express proteins can be expressed easier in our human cell lines. Moreover, with these human cell lines your protein will carry only fully human posttranslational modifications which might be more appropriate for therapeutic applications due to reduced immunogenicity and improved protein activity.
The capability of CHO cells ranges from high mannose structures to fucosylated complex N-glycan structures with up to multiple antennae. A general characteristic is a high sialylation in α2,3 linkage. For GEX® cells comparably lower amounts of high mannose are observed. The capping of N-glycans with sialic acid can be adjusted by chosing a different GEX® cell line. Process parameters during production are adjustable to trim distinctive glycosylation characteristics. A strong difference between both cell lines is GEX® capability to produce N-glycans with bisecting GlcNAc. BisGlcNAc plays a role in the efficiency of mAbs. Sialic acids in CHO derived material are exclusively linked in α2,3 conformation, whereas GEX® cells are capable of fully human α2,3 and α2,6 -linkages. Furthermore, both NeuAc and NeuGc are observed for CHO, in GEX® only NeuAc is present.
The capability of CHO cells ranges from high mannose structures to fucosylated complex N-glycan structures with up to multiple antennae. A general characteristic is a high sialylation in α2,3 linkage. For GEX® cells comparably lower amounts of high mannose are observed. The capping of N-glycans with sialic acid can be adjusted by chosing a different GEX® cell line. Process parameters during production are adjustable tAn RCB can be obtained already after 16 or 20 weeks for the CHOnamite® and GEX® platform, respectively. Depending on the customer’s requirement on clonality a second cloning round might be needed which takes 6-8 more weeks.
Cell Line Development Services – Related Content
Learn more about the the 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
Flyer Cell Line Development
Flyer Feasibility Study