BeiGene, Ltd., a biotechnology company, has recently gained approval from the China NMPA (National Medical Products Administration) to start the commercial supply of tislelizumab.
Tislelizumab will be produced at its state-of-the-art biologics plant in Guangzhou, China. It is a humanized IgG4 anti-PD-1 monoclonal antibody designed specifically to lower the binding to FcγR on macrophages, which can compromise PD-1 antibodies’ anti-tumor activity through the antibody-dependent and macrophage-mediated killing of effector T cells. Additionally, it is the 1st drug developed from the company’s immune-oncology biologics program, in combination with other therapies, to treat a range of solid tumor & hematologic cancers.
The wholly-owned facility, spanning nearly 1 million sq. ft. and 8,000 liters of biologics capacity being approved for the commercial supply, will immediately start producing tislelizumab for the China market. The company has started an additional phase of construction to bring the total capacity to 64,000 liters, which will be completed by 2022 end.
According to BeiGene’s President, COO, & General Manager of China, Xiaobin Wu, Ph.D., the company commenced the construction of the large-scale manufacturing facility in 2017 to cater to the exponential rise in demand in the future. Since then, the anti-PD-1 antibody has been approved for use in several indications across the country, included in the NRDL (National Reimbursement Drug List), as well as licensed to Novartis in Japan, North America, and Europe. With the robust pipeline of tislelizumab and other biologics, it will also place a high emphasis on ensuring the safety, quality, and compliance of its products.
The manufacturing facility in Guangzhou has been designed to function in compliance with the cGMP (current Good Manufacturing Practice) standards adopted by the EMA (European Medicines Agency), NMPA, and the U.S. FDA. The site is likely to operate as the 1st paperless biological manufacturing plant in China and integrate innovative technologies like AI, augmented interfaces, digital twin, and 3D modeling to drive efficiency and quality.