太阳集团0638（中国）责任有限公司

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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.

Hardware Facilities：
PK/PD evaluation

Assessment of PK, PD, immunogenicity in preclinical and clinical studies.

Hardware Facilities：
Process development and scale-up

Cell line development, upstream and downstream process development and pilot production.

Hardware Facilities：
Formulation development

Formulation and fill/finish process development for both vial and pre-filled syrings（PFS）

Hardware Facilities：
Antibody characterization

Characterization of primary, higher order structure of antibodies and post-translational modification; purity analysis and determination of product related impurities.

Hardware Facilities：
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）

Hardware Facilities：