Cell Line Development (CLD)
At Fonix Pharma, our Cell Line Development (CLD) services are the foundation for the successful and cost-effective production of premium biopharmaceuticals. Our systematic approach leads to stable, high-performance cell lines crucial for the final product's quality.
We leverage our advanced proprietary technology platform to rapidly generate highly productive monoclonal cell lines. This minimizes time-to-market while ensuring exceptional product quality. Our CLD success is owed to specially adapted CHO host cell lines, powerful expression vectors, and our top-performing First CHOice® cell culture medium and feeds.
Systematic Approach to High-Performance Cell Lines
A four-stage process lays the foundations for creating cell lines that express your target gene at high rates.
- Gene synthesis and cloning into proprietary expression vectors for high yield.
- Transfection of host cell lines (e.g., CHO‑DG44, CHO‑K1, CHO‑DXB11).
- Pool or mini-pool generation, high-throughput screening.
- Single-cell cloning (image-based monoclonality assurance).
- Selection of high-productivity clones.
- Expression stability studies.
- Cell bank generation (Research and Master Cell Banks).
- Proof of biological safety.
Regulatory Compliance and Documentation
The stability and safety of our cell lines meet the highest standards for fulfilment of regulatory guidelines. We work pursuant to EMA/410/01 in order to minimize the risk of TSE/BSE. We ensure that our cells have proven performance and quality that adheres to global standards.
Documentation Provided:
- Reports on vector construction, pool generation, clone generation and stability.
- Biological safety data.
- Documentation to ensure traceability.
- Certificates for contact materials and contact reagents used.
Need to discuss your specific cell line requirements?
Contact our team today