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Downstream Process Development

WuXi Vaccines’ Downstream Process Development (DSPD) team applies state-of-the-art technology in purification process development, process scale-up, process characterization, and technology transfer to cGMP production. DSDP has extensive experience developing purification schemes for a wide-variety of vaccines including VLP and recombinant protein subunit or antibody-based prophylactic vaccine approaches.



  • Downstream Process Platform


    • The DSPD team is capable of developing cGMP purification process for a wide-range of vaccine products to meet our customers’ needs. An array of chromatographic resins, including affinity, ion exchange, hydrophobic interaction, hydroxyapatite, mix-mode etc., can be screened. These downstream process development activities can be completed within a 12-24-week timeline.


  • High Throughput Process Development Platform



  • Continuous Processing Platform


      • WuXi Vaccines DSDP team of experts can establish new purification schemes or convert batch processes to a continuous process. We can work with our Upstream Cell Culture Process Development team to integrate downstream continuous process operations into one advanced continuous processing platform.


      • Convert Batch Process to Continuous Process-2 weeks


      • Reduce Protein A resin cost by up to 90%


      • Increase downstream productivity by 100%


    • Increase downstream capacity by 1000%


Continuous Processing Platform

To the support our client’s fully-integrated vaccines development programs, we offer customized stand-alone services to either develop entire purification schemes or single unit step operations or processes. The scope of our services include:


  • Purification Support:


    • Purification services to support clone selection and cell culture development
    • Drug substance generation to support analytical and formulation development activities


  • Early Phase Downstream Process Development: 


    • Bench-scale process development
    • Process scale-up in non-GMP pilot plant
    • Technology transfer for GMP production
    • Viral clearance studies (if required)



  • Late Phase Downstream Process Optimization:


    • Process optimization
    • Failure Modes and Effects Analysis (FMEA)
    • Scale-down model qualification for process characterization
    • Process characterization
    • Late phase viral clearance study (if required)



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