Mycenax Biotech Inc.

EN

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Downstream Process Development

Mycenax provides comprehensive process design and development for downstream process based on our experiences from diverse and complex products. Our in-house technology platforms shorten the time to GMP production and IND submission.
 

Our Capabilities

  • Development of purification processes including chromatography, tangential flow filtration (TFF), virus filtration steps
  • Optimization of individual purification steps
  • Development of virus removal strategy and conditions
  • Downstream process scale-up
  • Reliable technical transfer, verification and optimization of clients’ downstream processes
  • Process validation activities including scale-down model qualification, resin lifespan study, process characterization
  • Use of Mycenax’ proprietary technology platforms such as MBIFastTM, MBIMicro
 

Equipment and Technology

  • Chromatography
    • Ion exchange chromatography (IEHPLC)
    • Size exclusion chromatography (SEC)
    • Affinity chromatography using Protein A or Heparin
    • Immobilized metal affinity chromatography (IMAC)
    • Hydrophobic interaction chromatography (HIC)
    • Reverse phase chromatography (RPHPLC)
    • Mixed mode chromatography
  • KR2i semi-automatic TFF system
  • AKTA primeplus, AKTA purifier
  • Filter sizing (nanofiltration, 0.2 micrometer filtration)