Downstream Processing

Our expertise

Axys-Network assists companies from the first stages of product development to commercial manufacturing.

Training

  • Technologies used for protein recovery and purification (cell extractions, chromatography, filtration, centrifugation, precipitation, etc ...)
  • Analytical methods for process control and product characterization
  • Scale-up from laboratory to large-scale production
  • Technologies used to remove / inactivate Viruses and Prions
  • Stabilization of the product
  • Technical transfer (How to successfully complete your technical transfer)
  • Designing manufacturing processes for the future

New Process

  • Recovery and purification procedures
  • Scale-up to large-scale production
  • Process characterization studies
  • Viral risk reduction and vCJD strategy
  • Determination of key parameters
  • Regulatory support for CMC documentation and inspections
  • Establish a process control strategy (PCS)
  • Quality by design approach (QbD)

Process already established

- Process improvement and optimization


- Process characterization studies


- Technical transfer


- Comparability package for process modifications and / or for technical transfer


- Troubleshooting and technical surveys


- Regulatory support for CMC documentation and inspections