Our process focuses on the production of the rhNGF (recombinant human Nerve Growth Factor).
It is divided into two phases:
- 1. UPSTREAM
Active ingredient production
- 2. DOWNSTREAM
Active ingredient purification
Our system operates in compliance with current Good Manufacturing Practice (GMP) rules and is authorized by the EMA in Europe and FDA in the US.
THE CELL BANK
Composed of vials containing bacteria that are genetically equal, the cell bank is stored in an EMA and FDA-authorized repository that accommodates two liquid nitrogen (-173°C) cryogenic storage units and a freezer (-70°C). Each cryogenic unit may store up to 30,000 vials.
The cell bank is also stored off-site to guarantee preservation in case of natural disasters.
HOW A PROTEIN
- A genetic carrier (plasmid) containing the gene expressing the proNGF active ingredient is generated. This is the precursor protein of the mature NGF active ingredient.
- The plasmid is inserted in an E. coli bacterium. The genome and biological interactions of this living organism are known in detail as they have been studied by scientists for years. The modified bacterium generates clones which will add to the cell bank.
- The NGF protein expressed by these genetically modified bacterium is then extracted and purified.