Platform and Capability

技术平台

  • 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: