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.
 

 

MBIMicroP™

MBIMicroD™

Objective

  • 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

Features

  • 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