Mammalian

Downstream Process Platform

• • The downstream process development (DSPD) team can develop cGMP purification processes for a wide range of products to meet client needs. An array of chromatographic resins, including affinity, ion exchange, hydrophobic interaction, hydroxyapatite, mix-mode can be screened. These downstream process development activities can be completed within in 12–24 weeks.

High Throughput Process Development Platform

Continuous Processing

• • • Our team of DSPD 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 continuous processing platform.
  • • Convert batch process to continuous process in 2 weeks
  • • Reduce the Protein A resin cost by up to 90%
  • • Increase downstream productivity by 100%
  • • Increase downstream capacity by 1,000%

Continuous Processing

To the support our client’s integrated development programs, we offer customized standalone services to either develop entire purification schemes or single unit step operations or processes.

Purification Support:

• • Purification to support clone selection and cell culture development
  • DS 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)