Novel antibody development
Complete innovative antibody drug R&D platforms, including Ab discovery based on B cell cloning and phage display; Ab humanization, optimization and affinity maturation; Ab developability assessments based on in vitro/ in vivo activity, PK/PD and physicochemical property.
Assessment of PK, PD, immunogenicity in preclinical and clinical studies.
Process development and scale-up
Cell line development, upstream and downstream process development and pilot production.
Formulation and fill/finish process development for both vial and pre-filled syrings（PFS）
Characterization of primary, higher order structure of antibodies and post-translational modification; purity analysis and determination of product related impurities.
GMP manufacturing facility
The facility is under construction. Meet U.S., EU and Chinese cGMP requirements；4 x 2,000 L（by 2020); Two automatic pre-filling lines, one for vial and one for pre-filled syrings（by 2020）