Mycenax Biotech Inc.


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Process Characterization

Mycenax performs process characterization as a critical activity during process development. The generated data allow developing effective process control strategies for process validation and commercial manufacture.

Our Capabilities

  • Application of risk assessment methodologies (e.g. FMEA, fish-bone diagram, PHA, decision tree)
  • Design of experiment (DOE) matrix
  • Scale-down model study to provide evidence of
    • Effectiveness of cleaning process
    • Viral clearance validation
    • Impurity removal capability
    • Resin lifecycle
    • Membrane lifecycle
    • Microbial retention capability