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Cell Culture
High Titre, Robust Cell Culture

Segregated cell culture process development laboratories provide capability to identify top cell pools and clones, screen media, and optimize product expression and key quality attributes with the capacity to execute up to 4 upstream development programs in parallel.

Our Cell Culture Process development team has broad experience in different types of biologics. We utilize our experts’ deep process development skills, high- standard facilities, and rational experimental design, to establish robust, high-quality and low-cost cell culture processes covering every stage of biologics development.

Services

Media screening and feed strategy optimization

Process development in bench-top bioreactors

Process scale up study in pilot scale bioreactors

Product quality attributes optimization

Late stage process develop-ment and characterization

Material generation for pre-clinical studies

Typical Cell Culture Workflow

  • ~3 weeks

    Technology Transfer

    Technology transfer

    Cell line transfer

    Cell line in-house safety test.

  • ~6 weeks

    Media Screening in Shake Flasks

    Basal/Feed screening

    Quality attributes optimization

  • 6~8 weeks

    3L Bioreactor Runs

    Feed strategy optimization

    Parameter optimization (pH, Integrate Viability Cell Concentration, Temp., Growth profiles, Metabolism profiles, Titer, Aggregation, Charge, Glycosylation )

  • ~4 weeks

    Confirmation Runs 15-250L

    Process lock

    Process scale up

    Materials for down-stream process lock

    Cell culture process development report

  • ~12 weeks

    Pilot Scale Manufacturing

    non-GMP and GMP run

    Provide materials for toxicology studies, Viral Clearance studies, reference and IND filing

    provide materials for clinical trials