Lonza, a global contract development and manufacturing organization (CDMO), in a statement, said that it will invest to establish drug product manufacturing capabilities at its site in Guangzhou, China.
The new investment will fund the installation of an aseptic drug product fill and finish production line at the 17,000 m2 state-of-the-art cGMP mammalian facility. The Guangzhou, China, facility began operations in Q2 2021 and expects to deliver its first cGMP batch later this year.
The fill and finish production line will significantly expand the site’s capabilities, supporting global and domestic customers with supply for clinical trials and commercial batches in China. The introduction of drug product manufacturing at the Guangzhou site will provide a combined drug substance and drug product manufacturing service offering for customers, in line with Lonza’s strategy to provide integrated end-to-end solutions to customers.
The sterile, multi-product fill and finish line will support the filling of liquid and lyophilized products. The installation is expected to be completed in 2022 and will create more than 150 new positions at the Guangzhou site.
Expanding Center of Excellence
To facilitate the installation of the new drug product manufacturing line in Guangzhou, Lonza also plans to expand the footprint of its global Drug Product Services hub based in Basel, Switzerland.
Lonza’s Drug Product Services laboratories are a Center of Excellence, supporting drug product capabilities across the company’s global network by providing formulation development and process development.
“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,” said Hong Pan, General Manager, China, Lonza.
“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,” he added.
“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.”
Lonza Biologics’ Guangzhou facility offers comprehensive mammalian cell line, process and analytical development services, and cGMP production in 1,000L and 2,000L bioreactors. Single-use technologies are employed in both USP and DSP processes. The site supports clinical and commercial production of biotherapeutics and is located 38 km from Guangzhou Baiyun Airport.
Lonza has in the past helped develop and manufacture drugmaker Roche’s breast cancer antibody-drug conjugate (ADC), called ado-trastuzumab (Kadcyla®).
Highlights of prescribing information
Ado-trastuzumab (Kadculy®; Genentech/Roche)[prescription information]
Featured image: Lonza Biologics, Guangzhou. Photo courtesy: © 2021 Lonza. Used with permission.