Lonza, the Swiss biopharma CDMO partner, has announced an expansion of its highly potent active pharmaceutical ingredient (HPAPI) capacity for the specific support of antibody-drug conjugate (ADC) payload manufacturing.
The HPAPI expansion at its site in Visp is based on a tailored business agreement with a major biopharmaceutical partner that ensures ADC payload supply continuity and flexibility at reduced cost of goods. The plan encompasses two new manufacturing suites capable of handling compounds with occupational exposure levels down to 1ng/m3.
The first of the two new HPAPI suites specifically supports a global biopharmaceutical partner by securing the long-term supply of highly potent ADC payloads. The second suite will be available to other customers for similar HPAPI and payload development and manufacturing programmes.
Lonza said the expansion also increases its capabilities in providing fully scalable HPAPI and ADC solutions from lab to commercialisation.
“By ensuring critical supply for the treatment of cancer patients, we are supporting one of our global partners in the oncology field,” said Maurits Janssen, Head of Commercial Development of the API Business Unit at Lonza Pharma & Biotech.
According to Janssen, oncology continues to be the leading indication in biopharma and the main driver for bioconjugates. "We continue to increase capabilities and capacity to meet the HPAPI development and manufacturing needs of our partners," he added.
Lonza is an established partner in developing and manufacturing HPAPI, with more than 20 years’ experience in progressing more than 30 products from early-stage work to late-stage clinical or commercialisation.
The company has the capabilities in place to safely handle HPAPIs to exposure levels down to 100ng/m3 across all manufacturing scales. These new suites will extend the options for companies developing APIs with even higher potencies.
“Our customers developing highly potent medicines need a partner whom they can trust to handle these toxic substances and to deliver in sync with their needs, whether for clinical or commercial supply,” said Gordon Bates, President Chemical Division at Lonza Pharma & Biotech. “Combined with our expertise in biologics development, manufacturing, bioconjugation and sterile fill/finish, this new capability will offer further solutions for companies developing complex therapies.“
The expansion, Lonza said, underlines the strategic position of ADCs in the Lonza Pharma & Biotech portfolio, with the company developing and producing all components of this increasingly important cancer treatment: cytotoxic payloads, antibodies and the required linkers.
