In early clinical phases, speed, flexibility, and repeatability are critical for drug substance process development.

Our in-house experts maximize batch yield and reduce processing time for your molecule while developing an optimal process with long-term commercial manufacturing in mind.

• Extensive Process Capabilities
  • CHO cell culture experience in a wide variety of therapeutic proteins: monoclonal antibody, bispecific antibody, trispecific antibody, nanobody, fusion proteins, and other recombinant proteins
  • Multiple cell culture modes, including fed-batch, perfusion, high cell density inoculation, and concentrated fed-batch
  • Design of Experiment (DoE) studies to optimize media/feed strategy and parameters such as titer, charge isomerism, glycosylation,purity
  • Experience in establishing statistical models between cell culture process parameters and critical quality attributes to define the design space for process consistency and robustness
• Supply Chain Stability
  • Multiple types of bioreactors with various scales from global suppliers:
  • - Applikon glass bioreactors (3L, 7L, 15L)
  • - Chuyi glass bioreactors (3L, 7L, 15L)
  • - Xcellerex XDR single-use stirred-tank bioreactors(50L, 200L，500L,2000L)
  • - GE wave bioreactors (20, 50 L)
  • Proprietary cell culture media and customized media development, expanding options for manufacturing cost control