Manufacturing Monoclonal Antibodies (mAbs)
GEA is a leading specialist in the field of process equipment for liquid processing and metering for the pharmaceutical and biotech industries, including fermentation plant for the manufacture of products such as monoclonal antibodies (mAbs) for diagnostic and therapeutic purposes.
Monoclonal antibodies are known as targeted therapies because they work by targeting specific proteins on the surface of cells. Successfully used to treat cancers, tumors and other serious diseases, mAbs are — compared with other biopharmaceutical products — large proteins that require relatively high administration doses and traditionally necessitate high-volume manufacturing equipment/systems and facilities. GEA offers production systems for monoclonal antibodies that are produced in state-of-the-art stainless steel bioreactors by specific cell cultures.
From Culture to Harvest
The cell culture process is done in several steps, starting with 10 L precultures and successively cultivating intermediate batches up to a final production volume of up to 20,000 L. These systems comprise the vessel, with the stirrer as the core element, and peripherals such as temperature control systems, clean-in-place (CIP) components, aeration and deaeration systems, input systems and automated sensors, actuators and the operator interface.
Support processes, such as media preparation and harvest systems are also available from GEA. The process integration of separators and filters for the harvest step is also within GEA’s scope of service. Because of the high sensitivity of the cells and the need for operator and product safety, all GEA system components are designed according to the latest standards and have the highest grade of finish quality.