Mycenax Biotech Inc.

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Drug Substance Manufacture

Mycenax manufactures high-quality drug substances by fed-batch or continuous perfusion cell culture processes meeting GMP or non-GMP requirements for the respective development stage.

Our Capabilities

  • Manufacture of high-quality drug substance for commercialization
  • Full compliance with GMP including PIC/S GMP, 21 CFR Part 211, EMA, FDA and PMDA requirements
  • Use of Mycenax’ proprietary technology platforms such as MBIContiTM
 

Our Capabilities

Production Line 1

  • Perfusion cell culture: four 50 L WAVE single-use bioreactors (GE Healthcare)
  • Fed-batch cell culture: 200 L single-use bioreactor (GE Healthcare)
  • Separate purification columns: AKTAready Purification System (GE Healthcare)
  • Virus removal system
  • Tangential flow filtration (TFF) system

Production Line 2

  • Fed-batch cell culture: 50 L, 500 L and 2000 L single-use bioreactors (GE Healthcare)
  • Separate purification columns: AKTAready Purification System (GE Healthcare)
  • Virus Removal system
  • Tangential flow filtration (TFF) system: SUTFF system (Pall)
  • Continuous perfusion cell culture: two 50 L single-use bioreactors (Sartorius), full-line automatic controller (Mycenax), continuous purification system (Pall)

Production Line 3

  • Microbial fermentation: 50 L single-use bioreactor (GE Healthcare)
  • Separate purification columns: AKTAready Purification System (GE Healthcare)