What is custom cell line development?

Custom cell line development is the creation of a stable, monoclonal production cell line, typically CHO, that expresses your therapeutic antibody or protein at high titer and consistent quality. At ProteoGenix, it takes 3 to 4 months from gene to a characterized Research Cell Bank. It includes imaging-based proof of monoclonality (VIPS™), a yield guarantee of ≥1 g/L for standard IgG, and a royalty-free proprietary CHO-K1 host. The resulting cell line is ready for transfer to a GMP CDMO for clinical manufacturing.

How long does stable cell line development take?

Our workflow takes approximately 3–4 months from gene to a ready-to-transfer stable cell line. It includes stable pool generation, single-cell clone screening with VIPS™, clone selection and Research Cell Bank preparation.

What expression yield do you guarantee?

For standard IgG projects, we guarantee a minimum yield of 300 mg/L at the stable pool stage and 1 g/L at the monoclonal clone stage. For bispecific antibodies, engineered antibodies and other complex formats, performance targets are defined according to the project.

How do you document monoclonality for regulatory development?

We use VIPS™ single-cell dispensing and image tracking to document single-cell origin and subsequent colony growth. A monoclonality report is provided to support downstream CMC documentation for IND/CTA submissions.

Do all your solutions offer freedom to operate (FTO)?

No. We offer both solutions designed to provide freedom to operate (FTO) and solutions that are not specifically FTO. If you are looking for an FTO solution, we can offer our proprietary CHO-K1 cell line.

Which expression systems can be used for stable cell line development?

ProteoGenix can develop stable cell lines using CHO and HEK expression systems, with the host cell line selected according to the requirements of the project. Our proprietary CHO-K1 cell line is available for programs requiring an FTO solution.

Can the developed cell line be transferred for GMP manufacturing?

Yes. The development workflow is designed to facilitate downstream transfer and scale-up. Cell line history, characterization data and relevant development documentation can be transferred to the receiving manufacturing partner or CDMO.

What do I receive at the end of a cell line development project?

Standard deliverables include the selected stable clone, purified antibody or protein, monoclonality documentation, vector map and sequence confirmation at Research Cell Bank QC. Additional services such as MCB/WCB preparation, scale-up, process development and extended characterization are available on request.

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.

Day 0 single-cell verification High-resolution imaging at the time of dispensing documents the presence of a single cell.
Tracked colony growth Consecutive image tracking documenting single-cell division into a monoclonal colony.
Monoclonality report A record of clonal origin to support downstream CMC documentation.

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.

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.

FAQ

Custom cell line development:
your questions answered

Custom cell line development is the creation of a stable, monoclonal production cell line, typically CHO, that expresses your therapeutic antibody or protein at high titer and consistent quality. At ProteoGenix, it takes 3 to 4 months from gene to a characterized Research Cell Bank. It includes imaging-based proof of monoclonality (VIPS™), a yield guarantee of ≥1 g/L for standard IgG, and a royalty-free proprietary CHO-K1 host. The resulting cell line is ready for transfer to a GMP CDMO for clinical manufacturing.
For standard IgG projects, we guarantee a minimum yield of 300 mg/L at the stable pool stage and 1 g/L at the monoclonal clone stage. For bispecific antibodies, engineered antibodies and other complex formats, performance targets are defined according to the project.
Standard deliverables include the selected stable clone, purified antibody or protein, monoclonality documentation, vector map and sequence confirmation at Research Cell Bank QC. Additional services such as MCB/WCB preparation, scale-up, process development and extended characterization are available on request.

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.

Custom Cell Line Development Service

Achieve 1 g/L minimum or pay nothing

Your Cell Line. Your IP. No Downstream Royalties.

Guaranteed FTO

100% Client IP Ownership

Zero Royalties or Milestones