500 m2 Controlled cell culture laboratories and 200 m2 grade C clean room for cell banking;
Transfection, cloning, screening and evaluation of stable cell lines;
Establishment and verification of cell bank following cFDA guidelines and other regulations;
Capable of developing dedicated culture medium for specific cell culture project;
Process optimization to improve the yield and quality of cell expression products;
Validation of culture process at pilot scale;
Developing pilot scale process on solid stainless steel pilot production line or disposable skids;
Producing pre-IND and IND samples.
Capable of affinity chromatography media (Protein A) production for antibody capture step;
Over 1000 m2 Controlled protein purification and analysis laboratories;
Development of protein purification process by DoE and MVDA (multivariate data analysis) to obtain stable and reliable process;
Preparation and identification of trace proteins for analysis;
Formulation development for multiple types such as vial, lyo and PFS at lab and pilot scale;
Capable of producing pre-IND and IND samples at pilot scale with hundreds grams of product recovery.