Multi-kg production planned to serve growing oncology API market
Swiss group Lonza is to invest CHF24m (€19.1m) to expand its cytotoxic manufacturing capabilities in Visp, Switzerland, in response to demand for cytotoxic APIs used in oncology therapeutics, one of the fastest growing segments of the pharma and biotech industry.
Lonza currently operates high potency GMP laboratory suites on gram-scale. The investment will add multi-kilogram scale cytotoxic production capacity, which will enable Lonza to offer clinical and commercial production of cytotoxics – all within one dedicated facility. The expansion is expected to be completed in the second quarter of 2012.
These enhanced fermentation and chemical capabilities, along with existing bioconjugation expertise, will help Lonza to comprehensively address its customers’ cytotoxic manufacturing challenges.
‘This investment speeds our efforts to establish the Lonza Visp site as a Centre of Excellence for high potency manufacturing,’ said Stefan Stoffel, Head of Lonza’s Chemical Manufacturing Business Unit. ‘Lonza Visp will offer a fully integrated end-to-end development and manufacturing solution for a wide-range of technologies, including highly active pharmaceutical ingredients (HAPIs), cytotoxics, peptides and antibody drug conjugates (ADCs).’
The new facility will provide the necessary production lines to secure API supply and meet the regulatory requirements of the coming decade with strict focus on safe handling of compounds with low occupational exposure limits (OEL) to ensure employee and environmental safety. Currently, cytotoxic projects are being initiated within Visp’s state-of-the-art GMP laboratory suites. Upon completion of the expansion, Lonza can smoothly transition customer projects for scale-up in the new manufacturing facility.