Process Development

Cell Culture Development

AGC Biologics has extensive experience developing mammalian and microbial production cell lines. This experience combined with our advanced analytical capabilities enable us to identify and select clones that meet your product’s specific parameters and characteristics. After selecting the most appropriate clones, we optimize production conditions to develop a high productivity cell line, tailored to your specific product quality targets and target production level, designed for robust, scalable manufacturing.

Our mammalian cell line development capabilities include:

  • Man_Down_Line3_044_crop.jpgExtensive experience with multiple mammalian cell types and expression systems, including CHO DG44, CHOK1, HEK293, NS0 and PerC6
  • Our proprietary CHEF1® Expression Platform
  • Single-cell clone selection based on high titer and quality attributes
  • Custom CHO cell line, growth media and production feeds
  • Cell line stability analyses
  • cGMP cell banking and storage
  • Twelve weeks from transfection to clone selection
  • Expression of up to 4.5 grams / liter of antibody

CHEF1® Expression Platform for mammalian cell line development

AGC Biologics has developed a proprietary mammalian expression system, CHEF1®. This robust and scalable expression platform has been used extensively to create many clinical production cell lines. In addition, three commercial protein products on the market utilize the CHEF1 Expression platform. The CHEF1 integrated expression platform accelerates development of cell lines for cGMP production by using robust procedures and chemically defined media and feeds, to produce high levels of recombinant protein in rapid timeframes. For additional information on our CHEF1 Expression Platform and the solutions it offers our clients, please click here.

Our microbial cell line development capabilities include:

  • Demonstrated expertise with E. coli and Pichia microbial expression platforms
  • Experience with yeast secretion and E. coli periplasmic secretion, soluble and inclusion body expression
  • Cell line stability analyses
  • cGMP cell banking and storage services