Technology & Capacities
With Polymun's founder Hermann Katinger being a pioneer in the field of animal cell culture, Polymun has a long tradition in the development and production of biopharmaceuticals using mammalian cell culture.
CELL LINE DEVELOPMENT
Polymun is offering the establishing of high-yielding production cell lines using the BAC technology (see Zboray et al. 2015, Nucleic Acids Research) in a CHO host line adapted for optimal growth in chemically defined cell culture media. Clones are selected from single cells using the CellMetricTM (Solentim, UK).
The development of mammalian cell bio-processes is an important focus as it represents a core competence of Polymun′s founder, Prof. Hermann Katinger. The development specific to cell line and product includes batch, fed-batch as well as perfused high cell density cultivation systems. An ultrasonic device is used as cell retention for perfusion processes.
FERMENTATION, GMP PRODUCTION
Our focus is mammalian cell culture. Three separate production units are equipped in total with the following net fermentation volume of bioreactors:
- batch fed-batch: 1x 14 L (seed bioreactor), 1x 250 L, 2x 2500 L
- perfusion: 1x 14 L (seed bioreactor), 1x 100 L
- 1x 25 L (WAVE, GE Healthcare)
Polymun has gathered experience in designing purification processes for proteins of all kinds, for antibodies, hormones and enzymes. Polymun uses a variety of methods, combining them for each protein to create an optimal solution. Next to yield and purity with depletion of endotoxins, host cell protein and DNA or adventitious viruses, the focus is given on validation and scalability.
DSP, GMP PRODUCTION
GMP-compliance and industrial applicability are central to all operations. The downstream purification capacity matches our GMP fermentation capacity with process systems up to 600 L/h and 6 bar.
- depth filtration
- ultra/dia filtration
- sterile filtration
- nano filtration
- affinity (AC) e.g. protein A, specific antibody, specific ligand etc.
- ion exchange (IEX)
- hydrophobic interaction (HIC)
- reversed phase (RPC)
- mixed-mode (MMC)
- ammonium sulfate
FILLING, GMP PRODUCTION
- Manual aseptic filling of glass vials (2 mL to 20 mL) with up to 1,800 vials per fill
- Manual aseptic filling of plastic containers (various sizes and formats)
- Automated aseptic filling line for glass vials (2 mL to 20 mL) with up to 10,000 vials per fill
- Validation of filling process by media fills
Cell Line Development
Polymun is applying fed-batch process as well as perfusion processes, depending on the specific requirements of the protein.