Kelun-Biotech's production base is located in Strait Science and Technology Park, Wenjiang District, Chengdu City, Sichuan Province. The production base occupies an area of approximately 31,000m². The design and construction of the facilities meet the global regulatory requirements of NMPA, FDA and EMA, and has received NMPA GMP certification.
The established facilities cover the entire lifecycle of antibodies and ADCs from early clinical stage to commercial production. The production facilities have an annual production capacity of more than 50,000L of antibody drug substance, more than 12,000L of ADC API(mAb) and conjugate, as well as more than 17,000L of early-stage clinical antibody drug substance. At the same time, drug product filling lines that meet the production capacity of the drug substance and ADC production lines have been established.
Presently, the Company is actively expanding capacity through the construction of additional production lines and identification of external CDMO capacity to meet future production needs of the product pipeline and commercialized products.
