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Downstream Process Development

Downstream Process Development Platform has wide experience in purification process development, scale-up and manufacturing for antibodies and recombinant proteins. The whole process follows the ICH Guidelines and QbD Concept, and normally achieves a highly efficient, robust and scalable downstream process in 8-12 weeks, with an overall yield of around 70%.

Equipped with intelligent protein chromatography systems such as AKTA Pure, Avant , the platform has rich experience in process development of biologics like monoclonal antibodies, bispecific antibodies, multiple antibodies, fusion proteins, ADCs.

  • Chromatography process development & optimization
    Process development of depth filtration & ultrafiltration
    Virus clearance process development: low pH incubation, S/D treatment, nanofiltration
    Process characterization by scale-down model
    Impurity challenge and study
    Study of chromatography resin lifespan