Manufacturing of therapeutic antibodies
To manufacture therapeutic antibodies in a production scale, production equipments are very important. Kyowa Kirin owns a state-of-the-art factory that complies with GMP (Good Manufacturing Practice), an international standard for manufacturing control and quality control for drugs.
Manufacturing processes of therapeutic antibodies
1. Preculture
![](./images/fig_manufa01.jpg)
Thawing the frozen cells and culturing them for proliferation, while at the same time gradually expanding the scale of operations.
2. Main culture
![](./images/fig_manufa02.jpg)
Antibodies secreted from cells accumulate in the culture medium.
The size of a culture tank (bioreactor) is about 1 to 20 tons.
3. Purification
![](./images/fig_manufa03.jpg)
Using a centrifuge to separate cells from culture media. Then, using a filter, cell debris and the like are removed.
Using column chromatography or a special filter, only antibodies are separated from the culture after removing cells.
4. Filling
![](./images/fig_manufa04.jpg)
Additives are added to the purified antibodies and this mixture is filled to containers such as vials and syringes.
After undergoing a series of inspections, products are stored and transported under refrigerated conditions.