Lonza ups HPAPI manufacturing in China with new cGMP space

22-Mar-2022

The company has explained that the expansion focused on extending the capabilities and capacity of development laboratories and kilogram-scale cGMP manufacturing laboratories

Lonza, a global manufacturing partner to the pharma, biotech and nutrition industries, has completed its laboratory expansion at its active pharmaceutical ingredients (API) manufacturing site at Nansha, China.

The expansion focused on extending the capabilities and capacity of development laboratories and kilogram-scale cGMP manufacturing laboratories for clinical supply of highly-potent APIs (HPAPI).

The new capabilities will increase the laboratory footprint to 250 sqm

HPAPIs represent a growing part of the small molecules pipeline with special requirements related to equipment, process safety, containment, and facility design. HPAPIs currently form a large part of Lonza's small molecule development pipeline and the demand for manufacturing is growing. The new laboratories are part of the recent investment to expand the mid-scale manufacturing capacity at the Nansha (CN) site and add additional capabilities in Lonza's global HPAPI manufacturing network to meet growing customer demand.

Jan Vertommen, Executive Director, Commercial Development, Small Molecules, Lonza said: "With over 1000 HPAPIs in development across multiple indications, there is a growing need for HPAPI development and manufacturing capacity from early-phase to commercial. The new laboratories further strengthen our global HPAPI manufacturing offering, and we are pleased that the first European and US-headquartered customers have signed HPAPI programs for our new laboratories in Nansha."

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The laboratory capabilities will increase the laboratory footprint to 250 sqm and will be equipped with state-of-the-art analytical and manufacturing equipment. The new laboratories will begin operations in March 2022.

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Jason Zhang, R&D Director, Small Molecules API, Lonza, added: "The expansion of our HPAPI capabilities at Nansha enables us to enter HPAPI manufacturing to meet growing global demand, especially in supporting clinical trials in oncology. Our presence in Nansha allows us to leverage world-class, high-quality and reliable local suppliers of raw materials, thus further increasing the speed of problem-solving and manufacturing."

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