Custom Cell Line Development Service

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.

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.

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.

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.

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.

The best host depends on your molecule, expression requirements, licensing needs and downstream manufacturing plans. ProteoGenix offers CHO-K1, CHO-S, DG44 and HEK293 options, with our scientific team helping you select the most suitable platform for your project.

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.

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.

A stable pool is a population of cells that have undergone selection for stable expression of a recombinant protein or antibody. It allows early assessment of expression levels before individual clones are isolated.

A clonal cell line is derived from a selected single cell and provides a defined production clone for further characterization, stability assessment and cell banking.

At ProteoGenix, stable pool generation and single-cell cloning are integrated into the cell line development workflow.

Transient expression is generally suitable when you need recombinant antibodies or proteins quickly, without establishing a stable production cell line. It can be useful for early research, molecule evaluation and initial production requirements.

Stable cell line development is more appropriate when your project requires a selected production clone for longer-term manufacturing development, cell banking or future scale-up.

The choice depends on your required quantities, development timeline and downstream objectives. Our team can help identify the most suitable approach.

Yes. ProteoGenix supports stable cell line development for multiple antibody and protein formats, including bispecific and multispecific antibodies, Fc-fusion proteins, Fab, scFv, VHH and other recombinant proteins.

These formats can have different expression and development requirements from conventional IgG antibodies. The ≥1 g/L yield guarantee applies to standard IgG projects and should not be assumed to apply to complex formats. Project-specific requirements and applicable performance commitments can be discussed with our scientific team.