Lonza, a global development and manufacturing partner to the pharma, biotech and nutrition industries, has completed the expansion of its highly potent API (HPAPI) multipurpose suite in Visp, Switzerland. The expansion adds development and manufacturing capacity for ADC payloads, supporting the entire development and manufacturing pipeline from feasibility studies to commercial supply.

The expansion underlines the strategic position of ADCs in Lonza’s portfolio. Lonza develops and produces all components of these increasingly important therapies, including cytotoxic payloads, antibodies and the required linkers, and this latest investment signals continued momentum for Lonza in ADC development and manufacturing.

The ADC market is expected to grow strongly, driven by the growing demand for novel cancer therapeutics with higher targeting abilities. The recent expansion, extending the capacity of the kilogram-scale HPAPI multipurpose manufacturing suite, is well positioned to support this growth.

The new HPAPI suite enables handling compounds with occupational exposure levels down to 1 ng/m3, with a variety of containment solutions and a flexible setup. Equipment on-site includes reactor sizes from 1 L to 50 L with a temperature range of -80°C to +150°C, isolation and drying equipment, lyophilization and chromatography equipment for the manufacture of payload-linkers.

“The new expansion represents a key new asset for payload-linker manufacturing, enabling the production of these highly-potent compounds at scale with high flexibility for the execution of different types of operations,” said Giovanna Libralon, senior director, commercial development, small molecules, Lonza. “The extended capacity will allow us to respond to a growing global need for these therapies, especially in the oncology field.”

Iwan Bertholjotti, senior director, commercial development and strategic marketing, bioconjugates, Lonza, said, “Lonza’s expanded multipurpose suite enables customers to meet the growing demand for targeted cancer treatments by developing and manufacturing ADC payloads with increased speed, capacity and agility. With this new fully integrated offer in Visp, we simplify the supply chain under one roof: from the production of an antibody to the chemical synthesis of complex payload-linkers and bioconjugation.”

The expansion in Visp is supported by a dedicated team of experts who have produced more than 300 cGMP batches and developed 15 payload-linkers and 50 HPAPI programs in the past decade. This expertise is available to support customers in process development, clinical and commercial manufacturing.