Due to Covid-19 restrictions, the opening ceremony that followed the successful completion of the plant’s first process validation and the start of manufacturing for in-market supply was virtual.

The new facility can handle compounds with occupational exposure levels down to 1ng/m3, strengthening overall bioconjugation capabilities in Visp, the company said. Its operation is said to be complementary to the Basel-based CDMO’s full-service capability for HAPI from bench-scale through 10m³ scale.

Lonza said the expansion underlines the strategic position of ADCs in its portfolio – the company develops and produces all components of these increasingly important cancer treatments, including cytotoxic payloads, antibodies and the required linkers, at one site.

The first suite, which actually became operational in March, supports an unidentified global biopharmaceutical partner active in the oncology field, securing its long-term supply of highly potent ADC payloads. A second suite will become available to other customers early in 2021 for similar HPAPI and payload development and manufacturing programs.

Together the new suites will extend the options for companies developing APIs with even higher potencies, Lonza said. At the same time, they will increase the company’s capabilities to provide fully scalable HPAPI and ADC solutions from lab to commercialization, supporting the accelerated timelines that many drug programs in this category require.

Oncology continues to be the leading indication in biopharma and a key driver for highly potent ingredients such as antibody-drug conjugates, said Maurits Janssen, Strategic Business Development Small Molecules at Lonza. The CDMO continues to add capabilities and capacity to meet the increasing development and manufacturing needs of its partners in this field, he added.

Author: Dede Williams, Freelance Journalist