Stable Cell Line Development
Robust CHO-based cell lines for scalable, manufacturing-ready protein production
Achieve reliable, long-term protein expression with our stable cell line development services for recombinant proteins and monoclonal antibodies.
We develop high-performing mammalian cell lines with a strong focus on stability, documentation, and downstream manufacturability, ensuring your program is prepared for transfer to GMP production.
De-risk your path to GMP with early insight into manufacturability — reducing costly rework and delays later in development.
Titers up to 6 g/L • Stable pools in 8 weeks • Monoclonal lines in 16 weeks • 60+ generation stability • Royalty-free
Why Bioneer?
Many programs move directly from transient gene expression (TGE) and early internal development into GMP manufacturing — often leading to unexpected challenges in scalability, stability, or process robustness.
We can help you get your cell line and process ready for GMP.
By providing early insight into cell line performance and manufacturability, we reduce the risk of costly rework, delays, and surprises when scaling up.
How we help:
- Select clones with robust growth and high expression
- Produce stable, fully documented cell banks
- Provide process documentation ready for tech transfer
- Minimize the risk of changes or delays at GMP
The result is a cell line and process foundation that is high-yielding, stable, and ready for manufacturing from the start.
- Hørsholm, Main site and headquarters, 3350m2 state-of-the-art laboratories and offices
- Copenhagen, Site with 180m2 laboratories and offices
What you get
We provide a complete, end-to-end cell line development package — designed for speed, quality, and transferability.
Expression Systems and Platforms
- CHO-DG44, CHO-S, CHO-K1 (Fut8 KO) or your preferred system
- our proprietary BION-CHO 6.0 System™
A robust platform for the rapid generation of high-expressing, stable CHO-DG44 cell lines, supporting reliable production of mABs, bispecific antibodies (bsAbs), and enzymes - High-throughput clone screening using Ambr®
Timelines
- Stable Pools: ~8 weeks
- Monoclonal cell lines: ~16 weeks
Cell line characterization and documentation
- Research Cell Bank (RCB) tested for sterility and mycoplasma
- Monoclonality verified and documented
- Stability over 60 generations verified and documented
- BSE/TSE statement provided
- Documented cell line history
Performance
- Titers up to 6 g/L
- Consistent expression across generations
- Applicable across multiple recombinant protein modalities
Tech transfer readiness
- Fully characterised cell banks and process documentation
- Built for seamless transfer to any GMP CMO
- Designed to avoid repeating stability and development work
Commercial
- Royalty-free (single, affordable fee))
Performance
- Titers up to 6 g/L
- Consistent expression across generations
- Applicable across multiple recombinant protein modalities
Tech transfer readiness
- Fully characterised cell banks and process documentation
- Built for seamless transfer to any GMP CMO
- Designed to avoid repeating stability and development work
Commercial
- Royalty-free (single, affordable fee))
Assessing cell line performance
Our cell line development workflows are guided by data at every stage, from early pool generation to final clone selection.
Using high-throughput systems such as the Ambr250, we generate predictive performance data that enables:
- Faster identification of high-producing clones
- Improved confidence in scale-up
- Early assessment of manufacturability
This ensures your cell line is not only high-yielding, but also robust, stable, and suitable for downstream processing.
Representative example of clones selected in an internal CHO cell line development program.
Efficient identification of high-producing clones is achieved using production-relevant screening conditions, with clone selection typically completed within 10 weeks post-transfection.
Scalable and consistent process performance is evaluated across development scales, supporting reliable scale-up and transfer decisions.
The example below demonstrates process consistency from 250 mL to 10 L in fed-batch production, including aligned cell growth, viability, product titer profiles and product quality.
Representative example from internal CHO cell line development program.
Early insights into manufacturability are generated during clone selection and process development, enabling informed process strategy decisions.
How we work together
We work as an integrated extension of your team, ensuring your cell line development project progresses efficiently and transparently.
- Collaborative project design aligned with your product and development goals
- Dedicated project manager and direct access to scientists
- Transparent communication and clear data interpretation
- Flexible workflows that adapt as new data emerges
Our approach is pragmatic and focused, providing the data you need to make confident decisions at each stage of development.
Our Recombinant Protein Leadership:
- Søren Madsen, Protein Expression, Dept. Head, Ph.D
With extensive experience in recombinant protein production and cell line development, Søren leads our scientific teams in delivering robust, scalable solutions tailored to each client’s molecule and development pathway.
Our team
As part of our broader protein team, Christian Müller, PhD, Sr. Project Manager & Principal Scientist, and Alexandra Baer, PhD, R&D Manager, Mammalian Cell Line Development, bring deep expertise in mammalian cell line engineering and development, supporting the design of high-performing, fit-for-purpose cell lines.
Contact us for a free consultation
Interested in learning how we can support your project or pipeline?
We´re always happy to chat.
For further information please contact Sr. Business Development Manager Brahim Gargouri on bga@bioneer.dk or +491716319133
For further information please contact Sr. Business Development Manager Brahim Gargouri on bga@bioneer.dk or +491716319133
