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Lonza plans to establish drug product manufacturing capabilities at is site in Guangzhou, China, to produce clinical trial and commercial supply in the country.
Lonza announced on Aug. 23, 2021 that it is further investing in its new 17,000-m2 current good manufacturing practice (CGMP) mammalian facility in Guangzhou, China, to establish drug product manufacturing capabilities. As part of the new investment, the company will install an aseptic drug product fill/finish production line. The Guangzhou facility began operations in the second quarter of 2021, and Lonza expects to deliver its first CGMP batch later this year.
The installation of the aseptic fill/finish production line will supply global and domestic customers with clinical trial material and commercial batches in China and will support the filling of liquid and lyophilized products. Installation of this line is expected to be complete in 2022.
The addition of drug product manufacturing at the Guangzhou site will result in integrated drug substance and drug product manufacturing services. To facilitate the installation of the drug product manufacturing line, Lonza will also expand its global drug product services hub in Basel, Switzerland. The Basel hub provides formulation development and process development to support drug product capabilities across the company's global network.
"The investment in drug product manufacturing capabilities at Lonza Guangzhou not only demonstrates our commitment to the Chinese market but also marks an important milestone in achieving our long-term ambition of increasing drug product capacity and addressing growing customer demand for an end-to-end drug product solution. Through the expansion of our services at Lonza Guangzhou, we will have the capability to support our customers with the late-stage clinical trial and commercial development of potentially life-saving treatments," said Hong Pan, general manager, China, Lonza, in a company press release.
"The future expansion of our Drug Product Services in Basel will be a key enabler to support our integrated drug substance and drug product offering across modalities. Combined with the planned expansion of development services in Basel, the new drug product manufacturing line in China will allow us to extend our best-in-class offering to meet increasing customer demand," added Peter Droc, head of Drug Product Services, Lonza, in the press release.