The suites will be capable of handling compounds with occupational exposure levels down to 1ng/m3. This expansion will include suites capable of producing all components of antibody drug conjugates (ADCs), cytotoxic payloads, antibodies and required linkers.
Maurits Janssen, head of commercial development, API business unit at Lonza, told us that this agreement allows Lonza to provide flexible supply to keep up with customers’ requirements across phases of development.
“Bio-conjugates pose a complex challenge from a development and manufacturing perspective,” said Janssen. “The supply chain is complicated by the requirement for multiple complex drug intermediates (large molecule, highly potent small molecule and linker), which need to be available at the right time before drug substance manufacturing can begin.”
He further explained that simplifying the supply chain by manufacturing intermediates and the drug substance under one system at Lonza may reduce risk and accelerate the drug to clinical trials or market.
Janssen told us that the ADC products developed or manufactured at Lonza include 11 innovative new drug (INDs), nine new product introductions in commercial manufacturing and two with biologic license applications (BLAs). Lonza currently produces two commercial ADC therapeutics that are approved in over 60 countries.
The high potency active pharmaceutical ingredient (HPAPI) and ADC payload expansion are expected to be operational by the end of 2019.