Therapeutic Antibodies

Manufacturing of therapeutic antibodies

Therapeutic antibodies are manufactured, using cutting-edge technologies. Kyowa Hakko Kirin's biopharmaceutical production plant is equipped with the latest manufacturing facilities and is compliant with good manufacturing practices (GMP), which are international standard of manufacturing and quality control system to produce safe and effective drugs.

Culture

Illustration: The Antibody drug manufacturing process - Culture

- A vial of the cell bank is thawed and cultured in a medium. As the cells glow, the culture is moved into increasingly larger bioreactors.

- The plant contained multiple bioreactors which sizes are from 1 to 10 kL.

Photo: The Antibody drug manufacturing process - Culture

Cell removal

Illustration: The Antibody drug manufacturing process - Cell removal

- After the end of the production culture, the suspension is centrifuged and then filtered to remove any remaining cells / cellular debris.

Photo: The Antibody drug manufacturing process - Cell removal

Purification

Illustration: The Antibody drug manufacturing process - Purification

- The antibody is purified through multiple steps of chromatography, using large diameter (tens of centimeters to a meter) columns.

- Purified antibody is passed through a filter aseptically.

Photo: The Antibody drug manufacturing process - Purification

Fill/Finish

Illustration: The Antibody drug manufacturing process - Formulation filling

- In a stringently controlled clean environment, the therapeutic antibody solution is filled in small bottles (vials) and then sealed with a rubber plug and aluminum capping.

- The products are stored and delivered to customers in a refrigerated condition.

Photo: The Antibody drug manufacturing process - Formulation filling

There are also some technical hurdles that need to be addressed to manufacture therapeutic antibodies, such as construction of a highly productive cell line and optimization of its culture condition. Kyowa Hakko Kirin has a long-term experience of manufacturing biotechnology-based drugs and unique technologies which enable us to produce state-of the art biopharmaceuticals.