Manufacturing Process Development and Scale-up

Manufacturing Process Development and Scale-up

Cell culture process technology platform provides for the optimization of media, seeding densities, feeding and bioreactor process control strategies to maximize expression, and enhances process reproducibility and facilitate scale-up Adaption of cell line to...
Cell Line Development and Banking

Cell Line Development and Banking

Cell line development from DNA sequences to RCB stability assessment Traceability of host cell history and cell line generation process High productivity and robust stable cell line development platforms Well-equipped cell line development labs and clone...
Manufacturing Process Development and Scale-up

Developability Assessment

Potential CDR hot spots analysis  Biophysical characterization Stability studies High concentration possibility assessment      

GMP Production

Pilot scale capacities in Zhangjiang, Shanghai Capable of generating 500-1000g of DS per batch to meet pre-IND and phase I &II clinical demand Aseptic fill 2- 20 ml vials, up to 900-1800 vial/hr and 5000 vials per batch; 2.8m² freeze-drying shelf area for DP GMP...

Analytical Development and Testing

Our analytical capability includes both analytical development and testing for non-GMP samples and QC testing and releases for GMP drug substances and drug product.  Our rapidly growing Analytical Development & Quality Control team comprises 40+ scientists...