Tot Biopharm launches mAb manufacturing plant in China

By Flora Southey

- Last updated on GMT

(Image: Getty/邱 国标)
(Image: Getty/邱 国标)
Tot Biopharm has opened its second monoclonal antibody (mAb) production plant in Suzhou Industrial Park, China.

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.

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