Cell Line Development

High-Yield stable Cell Line Development Services

We deliver stable monoclonal cell lines producing recombinant proteins at titers ≥titer levels scoped per project.

Productivity guarantee – ≥titer levels scoped per project titer or the cell line is provided at no cost (scoped per project)
Monoclonality assurance verified by automated imaging and statistical.
Regulatory-compliant documentation including traceable cell banking.

From Gene to High-Yield Clone

Our integrated cell line development pipeline combines advanced vector design, high-throughput clone screening, and robust stability testing to deliver production-ready clonal cell lines for biologics manufacturing.

CHO and HEK293 host cells
Advanced screening with Solentim VIPS and Metrics
Scale-up from shake flasks to bioreactors

≥titer levels scoped per project Titer

Monoclonality Guarantee

Regulatory Support

Approach

Comprehensive Cell Line Development

We engineer high-performing clonal cell lines for stable expression of monoclonal antibodies and other recombinant proteins, combining proven host systems with advanced screening technologies.

High-Throughput Clone Screening

Rapid identification of top-producing clones using automated platforms that assess productivity, growth, and stability early in the workflow.

Solentim VIPS single-cell printing and imaging
CLD Metrics for monoclonality assessment
Fed-batch productivity assessment in Ambr 15 bioreactors

Stability and Scalability

Long-term stability studies across generations ensure consistent expression and product quality during scale-up to production-scale bioreactors.

Stability assessment over >60 generations
Scale-up from shake flasks to 2L bioreactors (as scoped)
Product quality attributes evaluated per client requirements

Vector Design and Transfection

Optimized expression vectors with strong promoters and selection markers are used to transfect CHO or HEK293 host cells, followed by pool selection.

Monoclonality Assurance

Each clone is derived from a single cell using imaging-based assessment, complying with regulatory expectations for clonal derivation documentation.

Cell Banking and Documentation

Master and working cell banks are generated under controlled conditions, with full traceability and stability data to support regulatory submissions.

Deliverables

What You Receive

Our standard deliverables are tailored to your project scope and include the following items upon completion.

Physical Deliverables

Stable clonal cell line (≥3 clones as scoped)
Documented research-grade cell bank (not a GMP master cell bank unless scoped) (MCB) and working cell bank (WCB).
Expanded cell culture documentation (passage history, growth curves)
Project-scoped documentation and materials as agreed at kickoff.

Documentation and Reports

Monoclonality report with imaging evidence
Stability study report (≥60 generations if scoped)
QC data: mycoplasma, sterility, identity (isoenzyme/STR analysis)
Regulatory support package (cell line history, vector maps, biosafety information)

Service Scope

Case-by-Case Project Scope

Each cell line development project is tailored to your molecule and timeline. The table below outlines typical parameters that can be customized.

Parameter	Typical project scope
Host Cell Line	CHO-K1, CHO-S, HEK293 (other upon request); evaluated during design phase
Expression System	Custom vector (CMV, EF-1α, or proprietary promoter); codon optimization and gene synthesis included
Transfection Method	Lipofection or electroporation; pool selection with antibiotic or glutamine synthetase (GS) system
Clone Screening Throughput	Scoped per project after consultation
Fed-Batch Productivity	Scoped per project after consultation
Stability Assessment	Scoped per project after consultation
Cell Banking	Scoped per project after consultation
QC Testing	Identity (isoenzyme/STR), mycoplasma, sterility, and endotoxin per ICH guidelines

Workflow

Our Cell Line Development Process

A streamlined, stepwise approach from DNA to production-ready clonal cell lines, designed for efficiency and regulatory compliance.

Vector Construction and Transfection

Gene synthesis and codon optimization; cloning into expression vector; transfection into host cells (CHO or HEK293) using optimized lipid or electroporation protocols.

Pool Selection and Enrichment

Stably transfected pools are selected under antibiotic pressure or metabolic selection; high-expressing pools are enriched via bulk sorting or limit dilution.

Single-Cell Cloning and Imaging

Automated single-cell dispensing into 96-well plates using imaging-based assessment (Solentim VIPS); each well imaged to confirm monoclonality.

Clone Screening and Top Candidate Selection

Growth and productivity screening in static and shake-flask cultures; top clones advanced to fed-batch evaluation for titer, growth rate, and product quality.

Stability Testing and Cell Banking

Lead clones undergo ≥60-generation stability study; upon passing criteria, MCB/WCB are generated, tested, and released with project documentation.

Applications

Typical Applications

Our cell line development services support a wide range of biologics programs.

Therapeutic Antibody Cell Lines

Generate high-yield clonal CHO cell lines for IgG, bispecific, or Fc-fusion protein production, with titers ≥titer levels scoped per project and robust scalability.

IgG1, IgG4, bispecific formats
Product quality assessment (aggregation, charge variants)
Fed-batch productivity optimization

Non-antibody Protein Expression

Stable cell lines for cytokines, growth factors, enzymes, and other complex recombinant proteins requiring mammalian glycosylation.

HEK293 or CHO host as required
Secreted or intracellular expression
Purification process compatibility review

Biosimilar Cell Line Development

Develop cell lines targeting a known innovator product; we provide analytical comparability data including glycan profiling and potency.

Target molecule analytical characterization
Reverse engineering of expression vectors (as allowed)
Reference product comparability studies

FAQ

Frequently Asked Questions

Common questions about our cell line development services and the deliverables you can expect.

Projects generally complete a timeline confirmed during project scoping, and stability study duration. Exact timelines are defined in the project SOW.
We use single-cell printing and imaging (Solentim VIPS) to document that each clone originates from one cell. A monoclonality report with time-lapse images and statistical metrics is included in the final deliverable package.
Our productivity guarantee is scoped per project: if the final selected clone fails to meet the agreed titer threshold (e.g., titer levels scoped per project), the cell line is provided free of charge. Acceptance criteria are defined upfront in the SOW.
Yes, we offer HEK293-based cell line development for proteins that require human glycosylation patterns or for transient-to-stable transitions. The workflow is adapted for HEK293 growth conditions and selection systems.
Standard QC includes mycoplasma detection, sterility (bacterial/fungal), cell line identity (isoenzyme or STR profiling), and endotoxin testing. Additional product-specific assays can be added as scoped.

Scientific Literature

References

Pulix M, Lukashchuk V, Smith DC, et al. Molecular characterization of HEK293 cells as emerging versatile cell factories. Current opinion in biotechnology. 2021;71:18-24. View on PubMed
Goerdeler F, Narimatsu Y, Büll C. Cell-based mucin arrays. Methods in enzymology. 2026;732:177-218. View on PubMed
Fu Y, Han Z, Cheng W, et al. Improvement strategies for transient gene expression in mammalian cells. Applied microbiology and biotechnology. 2024;108(1):480. View on PubMed
Dyson MR. Fundamentals of Expression in Mammalian Cells. Advances in experimental medicine and biology. 2016;896:217-24. View on PubMed

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