Home » Biologics CDMO » Antibody & Protein CMC Solutions for CGT
  • 5 Flexible packages for CGT

      5 Flexible packages for CGT:

    • GMP material
    • API apply for IIT and IND
    • ABP apply for IIT and IND
    • * API (Active Pharmaceutical Ingredient)
      * ABP (Antibody Product)

  • Fast timeline

      Fast timeline:

    • 5 months from DNA to GMP batch
    • As fast as 3.5 months from DNA to IIT material
    • As fast as 5.5 months from DNA to Tox batch
  • Robust cell line & PD platform

      Robust cell line & PD platform:

    • High-expressing cell line platform, ProBox for process development and analytical development
    • Successfully delivered bsAb & protein CMC:
      • Trispecific antibody
      • Ab-cytokine conjugate
      • Cytokine
    • * ProBox: Highly-efficient solutions for antibody development

  • Unique small scale CHO-derived GMP manufacturing facility

      Unique small scale CHO-derived GMP manufacturing facility:

    • EU QP audited facility and quality system
    • Support 25L to 500L production volume in GMP facility
      • 5*25L wave
      • 2*50L bioreactor
      • 8*200L bioreactor
      • 2*500L bioreactor

Capabilities of Development and Manufacturing

  • Platform Cell Line

    Platform Cell Line
    (ProCLD)

    • Rich experience in cell line development (180+projects)
    • Short timeline (12 weeks)
    • High productivity (up to 13.6g/L)
    • Proprietary expression vector
  • Platform Process & Analytical Development

    Platform Process & Analytical
    Development

    • Robust and efficient platform process and method development
    • ProBox: solutions for bispecific antibody and protein development
  • Small Scale GMP Protein Manufacturing

    Small Scale GMP Protein
    Manufacturing

    • Completely animal-free
    • EU QP audited facility and quality system
    • Support various scale:25L,50L,80L,100L GMP manufacturing

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