Development

Cell Culture - From Cell Line Development to Pilot Production

Core competencies:

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.

Protein Preparation - From Purification to Drug

Core competencies:

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.