Mammalian

• 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)