Lonza Completes HPAPI Expansion at Visp
Lonza has completed of the expansion of its Highly Potent API (HPAPI) multipurpose suite at the Basel-based CDMO’s alpine production site in Visp, Switzerland, adding development and manufacturing capacity for ADC payloads.
The move supports the entire development and manufacturing pipeline from feasibility studies to commercial supply and underlining the strategic position of ADCs in the company’s portfolio. It now has enhanced in-house capability to develop and produce all components, including cytotoxic payloads, antibodies and the required linkers.
Extending the capacity of the kilogram-scale HPAPI suite leaves Lonza well positioned to benefit from the growing demand for the payloads in novel cancer therapeutics with higher targeting abilities, the Swiss player said.
Utilizing the new capability, the CDMO will be able to handle to 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 liter to 50 liters with a temperature range of -80°C to +150°C, isolation and drying equipment, lyophilization and chromatography equipment for the manufacture of payload-linkers.
Lonza’s latest 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 for commercial development in oncology.
“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,” added Iwan Bertholjotti, senior director for commercial development and strategic marketing.
Lonza said 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.
Author: Dede Williams, Freelance Journalist
