The upgrade, which increases the laboratory footprint to 250 m² is part of plans announced in mid-2021 to extend the capabilities and capacity of development laboratories and kilogram-scale cGMP manufacturing laboratories for clinical supply of highly-potent APIs (HPAPI).

As part of the investment, three 1,000-liter GMP trains with an overall 12 m³ of reactor volume were added to the facility, along with new development and GMP laboratories with capabilities to manufacture small-scale batches of the HPAPIs.

Lonza said earlier that the higher scale capacity will facilitate mid-scale manufacturing to ensure a smoother transition between early-phase and large-scale commercial production and benefit the many global emerging biotechs with which it partners.

HPAPIs, which represent a growing part of the small molecules pipeline with special requirements related to equipment, process safety, containment, and facility design, currently form a large part of Lonza’s small molecule development pipeline and the demand for manufacturing is growing, especially in supporting clinical trials in oncology, the company said.

Author: Dede Williams, Freelance Journalist