Approved cGMP Manufacturing Production Facilities by US FDA
Celltrion cGMP facilities, Plant 1 and Plant 2, used in the manufacturing of multiple products, were designed and constructed following guidelines set forth by the US FDA and EU EMA regulatory agencies.
Celltrion is planning to increase the capacity of the existing plant1 to 50,000 liters and expand total manufacturing capacity by building plant3.
Quality Competitiveness > High Global Technology standards and in depth, Manufacturing know-how
Biologics preparations and protein based pharmaceuticals require a much more complex and advanced production operations and higher technology applications in contrast to chemically synthesized pharmaceuticals. Higher technology standards, state of the art facilities, in depth production know-hows, plus consistent process maintenance ensure the safe and sterile product manufacturing of Biologics. Celltrion presents one campus comprising of separated Biologics production facilities adding to a total capacity of 140,000 liters of bulk manufacturing including full Drug product manufacturing capabilities. Each manufacturing facility was designed and built using the US FDA cGMP and EU GMP guidelines as baselines. All facilities in our plants are constantly undergoing production facility maintenance and focused value process improvements managed through Celltrion’s rigorous quality management system.
Price Competitiveness > The World’s Class
An essential element in the successful operation of a Biologics company is the presence of large scale manufacturing plant as it determines the production costs adding price competitiveness to manufactured products. Celltrion presents the world’s largest capacity for producing and supplying mAb (monoclonal antibody) Biosimilars – Celltrion is capable of producing biologics with a scale of over 1.4 million injections per year when judged on the criteria of anticancer antibody pharmaceuticals. Celltrion is planning to build the third manufacturing plant to meet the increasing demand for our products. This new facility will increase Celltrion’s total throughput to global top level.