Cell Line Development

Systematic approach to the development of stable high-performance cell lines

Stable cell lines underly successful production of biopharmaceuticals. Our cell line development (CLD) process allows for individual adaptation to specific issues and challenges – thanks to cutting-edge technology and analytical methods. A four-stage process lays the foundations for creating cell lines that express your target gene at high rates. The success of our CLD process is owed to specially adapted host cell lines, derived from CHO cells, and powerful expression vectors, as well as our top-performing First CHOice® cell culture medium and First CHOice® feeds.

Overview of the CLD process at UGA Biopharma:

Our cell line development services:

  • 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
  • Selection of high-productivity clones
  • Expression stability studies
  • Cell bank generation
  • Proof of biological safety

Detailed documentation in line with regulatory requirements

Our CLD team creates highly productive cells with proven performance and quality: 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 provide all the necessary documentation:

  • Reports on vector construction, pool generation, clone generation and stability
  • Biological safety data
  • Image-based monoclonality assurance
  • Documentation to ensure traceability
  • Certificates for contact materials and contact reagents used
Should you have any questions on cell line development, please get in touch!