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THERAPEUTIC ANTIBODIES & PROTEINS

Custom Cell Line Development Service

Develop a high-yield stable cell line for therapeutic antibody and protein production — royalty-free & FTO, with documentation supporting your path toward IND and GMP manufacturing.

✓

≥1 g/L guaranteed — or you don’t pay

Guaranteed performance. Lower development risk.
FDA/EMA compliant proof of monoclonality CQA characterization for preclinical development GMP-ready through our CDMO network
 

Start Your Project See Development Workflow

DERISKING

Achieve 1 g/L minimum or pay nothing

We share your risk. If we fail to achieve our minimum yield guarantee, our “No Result, No Fee” policy applies.*

  • 300 mg/L
    Minimum guaranteed yield

    Stable pool stage

  • 1 g/L
    Minimum guaranteed yield

    Monoclone stage

*Project-dependent. These guarantees apply to standard IgG antibody projects. Bispecific antibodies, engineered formats, and non-antibody protein projects typically have different expected yields; guarantee levels are confirmed case by case.

Royalty-free cell line development

Your Cell Line. Your IP.
No Downstream Royalties.

Keep control of the developed cell line and avoid downstream commercial constraints as your program advances.

  • 01

    Guaranteed FTO

    Licensing-free cell line development with no downstream IP restrictions.

  • 02

    100% Client IP Ownership

    Full rights to the developed cell line, constructs and documentation.

  • 03

    Zero Royalties or Milestones

    No royalties, milestone payments or licensing fees.

FROM DEVELOPMENT TO MANUFACTURING

From Stable Cell Line to GMP Manufacturing & Tech Transfer

Full IP ownership is just the first step. We ensure your cell line is technically and documentally ready for seamless clinical manufacturing, with zero vendor lock-in.

  • GMP-Compatible Development

    Cell lineage history, raw-material traceability and scale-up information structured for downstream cell banking and transfer.

  • CDMO Network

    Access to CDMO partners selected according to clinical timeline, market, production scale and budget.

  • Technical Handover

    Documentation and technical support to facilitate transfer to the receiving manufacturing partner.

Regulatory readiness · Therapeutic programs

Documentation Supporting IND & CTA Submissions

From documented single-cell origin to characterization of selected clones, generate evidence to support downstream CMC and regulatory development.

See an example of VIPS Monoclonality Report

VIPS™ · Monoclonality documentation

Traceable from Day 0

Single-cell dispensing and image tracking provide a documented record of clonal origin.

  1. Day 0 single-cell verification High-resolution imaging at the time of dispensing documents the presence of a single cell.

  2. Tracked colony growth Consecutive image tracking documenting single-cell division into a monoclonal colony.
  3. Monoclonality report A record of clonal origin to support downstream CMC documentation.

Critical Quality Attributes & Biophysical Profiling

We perform full characterization on top clones to validate structural and functional integrity before cell banking

  • Purity & Aggregation

    SEC-HPLC · SDS-PAGE · UV280
    Monomer content, aggregates & product-related impurities
  • Target Affinity & Kinetics

    Biacore™ X100 (SPR) · SPRi · FACS
    Binding affinity (KD) & kinetics
  • Structural Integrity & Mass

    Glycan profiling by LC/MS
    Molecular mass, structural integrity & glycosylation
  • Biophysical Stability

    Differential Scanning Calorimetry (DSC)
    Thermal stability & potential stability liabilities
  • Functional Potency

    ADCC assays · ELISA
    Biological activity & functional response

Stable cell line development workflow

From gene to your stable cell line
in 3 to 4 months

A milestone-driven workflow with Go/No-Go decisions at key stages, so you can review results before moving forward

Step What happens Timeline
Preliminary transient expression evaluation

Optional

Gene synthesis, subcloning, and transient expression to de-risk construct expression before entering stable line development.

⮂ Go/No-Go decision

2-3 weeks
Generation of Stable Pools MSX-based selection of stable CHO-K1 pools, screening by ELISA and antibody titration, and selection of your top-performing pools.

⮂ Go/No-Go decision + 300 mg/L guarantee

6-11 weeks
Single Cell Clone Screening by VIPS™ Automated single-cell seeding with real-time imaging, monoclonality documentation, and screening and ranking of your top clones.

⮂ Go/No-Go decision + 1 g/L guarantee

8-11 weeks
RCB Preparation and Stability Study Freezing of Research Cell Banks with full QC. Stability is monitored over 15 generations as standard, extendable to 60 generations on request. 4-5 weeks
(15 generations)
Total From gene to a ready-to-transfer stable cell line 3-4 months

Get a free quote

PROJECT DELIVERABLES

Standard Deliverables & Optional Add-ons

Core materials and documentation are included in your cell line development project, with additional services available according to your program needs.

Optional Add-ons

Available on request

Extend the standard program with additional banking, scale-up, characterization or process development services.

Available on request

  • ✓ Master Cell Bank (MCB) / Working Cell Bank (WCB)
  • ✓ Scale-up & bioreactor development
  • ✓ Upstream & downstream process development, including media/feed and purification optimization
  • ✓ CMC support & biosimilar comparability
  • ✓ Glycan profiling & intact mass analysis
  • ✓ Extended stability studies up to 60 generations
  • ✓ BLI Octet / Biacore ranking versus ELISA

Optional services can be selected according to the stage and technical requirements of your program.

CHO & HEK cell line development

Select the host cell line that fits your program

Choose among CHO and HEK options according to molecule, development strategy, scale-up needs and downstream manufacturing requirements.

  • Proprietary CHO-K1

    Our proprietary CHO-K1 cell line provides an FTO option for programs requiring greater commercial freedom.

    Licensing: one-time fee model.

  • CHO-S™

    A scalable CHO option for progression from research into larger-scale production.

    Licensing: no license fee before commercial use.

  • DG-44

    An established CHO host used for therapeutic protein development and production.

    Licensing: no license fees for early use.

  • HEK293 / 293F / 293E

    HEK variants for recombinant protein production and applications requiring a human-cell expression background.

  • Customer-Specific Cell Lines

    Development can be adapted around a customer-selected host when project requirements call for a specific system.

  • Not sure which host?

    Our scientists can review your molecule and downstream requirements before defining the development strategy.

    Discuss Your Project

Supported antibody & protein formats

From Standard IgG to Complex Therapeutic Formats

Our stable cell line development platform supports therapeutic antibodies and recombinant proteins across standard and more complex molecular formats.

300+ projects supported across stable cell line development programs
IgG1 / IgG2 / IgG4 Bispecific antibodies Multispecific antibodies Fc-fusion proteins Fab scFv VHH Therapeutic proteins Enzymes

Data report

8.35 g/L with licensing-free random integration

Random integration combined with high-throughput VIPS™ screening is a regulatory-proven strategy widely used in commercial biomanufacturing. Screening a broad genetic landscape identifies the rare, top-tier clones capable of exceptional productivity.

In a recent project, our platform took a therapeutic antibody candidate from gene synthesis to scale-up. Stable pools reached up to 1.53 g/L. After VIPS™ screening and ranking, the selected clone reached 8.35 g/L in a 1 L fed-batch process, with >99% purity. Our platform productivity record is 10 g/L.

⭢ Download the full Data Report

  • 1.53 g/L

    Best stable pool yield

  • 8.35 g/L

    Achieved at 1L fed-batch scale-up

  • >99%

    Final antibody purity

FAQ

Custom cell line development:
your questions answered

LET’S DISCUSS YOUR PROJECT

Ready to Develop Your Stable Cell Line?

Tell us about your therapeutic antibody or protein project. Our team will help you define the next steps, from cell line development to downstream manufacturing.

  • CHO and HEK expression options
  • Defined Go/No-Go checkpoints
  • Development and manufacturing transfer support

? Not sure where to start?

Already have a gene sequence, expression construct or an existing cell line? Tell us what you have and what you need to achieve. Our team will help identify the appropriate development approach.

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