Custom Protein Generation

Drug Substance Manufacture

Drug Product Fill & Finish

Development

Testing

Discovery

Antibody Drug Conjugates

Technologies & Platforms

 

Wuxi Biologics 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.

 



CLD-Program-features  HUB_and_SPOKE_Antibodies-Wuxia

    • Proven cell line development platform – over 200 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 >3 g/L) with exceptional stability
    • Same vector system and host cell line platform for early stage protein generation/drug candidate evaluation 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

 

 

 

wuxia-flawless-logo-small

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.

 


 

Wuxia-CHO-K1

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

Cell-Line-Development-Process-Flow-1

 

 
Host Cell Vectors Licensing Fee Cost License Terms Timeline (DNA to Top 3 Clones) Typical Productivity (g/L) Maximum Productivity (g/L) Ideal Applications
Wuxia_Logo_Web_smallCHO-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.

Instrumentation includes:

  • 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:

Developability assessment

Balancing expression level and product quality

FUT8 KO using CRISPR/Cas9 Technology

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