Sichuan Kelun Biotech Biological Pharmaceutical Co., LTD. is located in Haixia Science and Technology Industrial Park, Wenjiang District, Chengdu City, Sichuan Province, with built out capacity covering an area of about 31,000m². The construction standard meets NMPA, FDA and EMA requirements and has passed NMPA GMP inspections.
The production capacity covers the entire product lifecycle of antibody and ADC early clinical to commercial drug substance and drug product. Annual production capacity is more than 50000L of antibody drug substance cell culture, more than 12000L of ADC drug substance, and more than 17000L of early clinical antibody drug substance cell culture.At the same time, production of antibody and ADC drug products match the production capacity of the drug substance. Annual capacity of antibody drug products is 60 batches (750,000 vials) of freeze-dried antibody drug product or 100 batches (2.6 million vials) of injectable antibody drug product. Annual capacity of ADC drug products is 50 batches (1.4 million vials) of freeze-dried ADC drug product or 100 batches (2 million vials) of injectable ADC drug product.
According to the product pipeline development forecasts and future commercial production needs, we are planning to expand internal capacity as well as utilize CDMO capacity to match future product production needs.
