Caption: Monoclonal antibodies form the newest and most complex type of biosimilar. They are composed of more than 20 000 atoms.
Biosimilars are copycat drugs of original biologics, which include such things as monoclonal antibodies, hormones and enzymes. Due to the complex structure and mode of action of the molecules and the highly sensitive manufacturing process, biosimilars are not exact copies of the active ingredients, unlike small-molecule generics. They are similar, but not exactly the same (generic).
Programmed cells from the freezer. The starting point for the biosimilar manufacturing process are genetically modified cells that have been programmed to produce the active ingredient. They are stored at –150°C in the cell bank.
Production in fermentation vessels. In the active-substance factory, the cell solution is nourished and multiplied. Within five weeks, 13 000 liters are produced from one milliliter. During this phase, the cells also produce the active ingredient.
Isolation and purification. From the 13 000 liters, 200 liters of active-ingredient solution are separated from the cells. Purification processes such as chromatography are used to isolate the protein molecule active ingredient.
Formulation and filling. In formulation, the dosage, pH and stability of the biosimilar drug are precisely adjusted. Subsequently, the finished product is filled into ready-to-use syringes, for example.
