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)