Cell Line Development
Proven, high-yielding development platform accepted by regulatory agencies worldwide
WuXi Biologics offers comprehensive mammalian cell line development (CLD) capabilities for a wide variety of antibody and protein therapeutics. Our program typically starts with client-provided DNA or protein sequences and ends with the delivery of high-yielding, well-characterized, stable, single clones.
Fully integrated with WuXi Biologics’ upstream process development, analytical and GMP cell banking and characterization services, our cell line development program provides a single source for all your R&D and CMC outsourcing needs for protein production using mammalian cell lines.
- Proven cell line development platform – over 160 cell lines developed for use in clinical trials and beyond
- Open-access technology with low licensing fees and flexible terms
- Robust cell line with high productivity (typical mAb titers of 2.5-3.5 g/L) with exceptional stability
- The same vector system and host cell line for transient production and stable cell line development
- Research and GMP cell banking and supporting in-house cell line characterization services (per US FDA / ICH guidelines)
- Seamless and efficient integration with process development and cGMP manufacturing services
- Ideal for monoclonal antibodies, bispecific antibodies, fusion proteins, enzymes and other recombinant proteins
The Chinese word “Wuxia” translates to “Flawless / Ideal” in English. Hence why we chose that word to describe our cell line development (CLD) platform. Our CHO-K1 is the ideal cell line development and protein expression system for biological therapeutics. Using the Wuxia proprietary vector system in CHO-K1 cells, our cell line group has developed a process that can deliver top 3 clones in just 12 weeks at titers up to 8 g/L! The Wuxia CHO-K1 system has already been used for production of >160 biologics for INDs and beyond.
Our proprietary technology married with lower IP licensing terms compared to other competitive cell line systems makes our CHO-K1 platform the best value for your biotherapeutic development programs.
A Streamlined CLD Process
|Host Cell||Vectors||Licensing Fee Cost||License Terms||Timeline (DNA to Top 3 Clones)||Typical Productivity (g/L)||Maximum Productivity (g/L)||Ideal Applications|
|CHO-K1||CHO-K1||Proprietary||Low||Flexible||12 Weeks||2.5 ~ 3.5 (Clone)||~8||Stable / Transient|
Equipment & Instrumentation
Our well-equipped state-of-the-art molecular biology and cell biology labs offer the full range of services required for successful cell line development processes.
- Incubators for high-throughput cell culture in spin tubes, 24-well plates, and shake flasks
- High-throughput expression and glucose / Lac assays
- Automated high-throughput clone screening
- High-throughput cell counting
- Automated clone picking
Comprehensive Supporting Services
WuXi Biologics offers an extensive list of CMC services that can be integrated and often conducted in parallel with our cell line development services – all using the same cell line platform.
Cell Line Development Case Studies: