Mycenax Biotech Inc.


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Microbial Process Development platform

Mycenax’s Microbial Process Development platform saves costs and time for products manufactured by microbial fermentation with E. coli including recombinant proteins as well as plasmid DNA.





  • Establish a high cell density fermentation process within 12 months from DNA sequence to GMP manufacture of the drug product
  • Establish manufacturing process for high-quality GMP-grade DNA within a few months


  • Well established platform with a proven track record from numerous projects including soluble recombinant protein, inclusion bodies, and PEGylated proteins
  • Use of large-scale single-use bioreactor and downstream purification systems
  • High cell-density GMP compliant processes with yields above 250 g
  • Tag system for protein purification with high recovery
  • No use of animal-derived components in the process
  • Optimized for manufacturing of plasmid DNA intended as ancillary material for cell and gene therapies and as a pharmaceutical product for DNA vaccines
  • High-quality GMP-grade plasmids with process yield up to 100 g
  • No use of animal-derived components in the process

Technology Platform

  • Research cell bank generation
  • Development of a robust and scalable process for recombinant protein or plasmid DNA production
  • Development of high cell density fermentation process
  • Development of purification process (chromatography, TFF, virus filtration)
  • Development and qualification of analytical methods
  • Production of GLP material at pilot scale
  • Technical transfer to GMP production