Biotech
production

Our process focuses on the production of the rhNGF (recombinant human Nerve Growth Factor) biotechnological active ingredient.

It is divided into two phases:
  • 1. UPSTREAM
    Active ingredient production
  • 2. DOWNSTREAM
    Active ingredient purification

Our system operates in compliance with Good Manufacturing Practice (GMP) rules and is authorized by the EMA in Europe, FDA in the US and NMPA in China.

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
IS EXTRACTED

  1. 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.
  2. 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.
  3. The clone used to create the cell bank is generated from this bacterium.

Dompé Farmaceutici S.p.A. Single shareholder company / Share capital € 50.000.000,00
REA MI 289519 - A registered company in Milan, Italy / Tax code and VAT number IT00791570153