The Chinese biopharmaceutical company has launched a 16,000L capacity mAb production site with upstream R&D, pilot-scale, clinical, and commercial production facilities.
Tot Biopharm will also use the 13,000m² plant – which houses lyophilisation capabilities for antibody-drug conjugates (ADCs) – for commercial-scale production of both biologic and small molecule drugs.
The company initiated construction in 2016 in response to growing demand for oncology drugs. At the time, we reported that the firm planned to install disposable bioreactors and processing systems to build five production lines with a cell culture capacity of 2,000L.
The firm’s specialised cancer drug production plant, including a 500L biologic pilot plant, a BSL-2 certified viral facility, an OEL-5 isolator for ADCs, and a small molecule site, was completed in 2012.
The new mAb facility joins a growing number of antibody production plants in China. Germany-headquartered Boehringer-Ingelheim launched its mammalian cell culture facility in Pudong, Shanghai last year, and in January announced it had made its first commercial mAb – BeiGene’s tislelizumab – at the facility.
Earlier this week, Chinese contract development and manufacturing organisation (CDMO) WuXi Biologics broke ground on an ADC centre in Wuxi City, near Shanghai.