The newly opened €59m (US$62m) facility covers 70,000 sq ft (6503.2 sq m) and brings 50 new jobs to the area.
HPAPIs are used in novel cancer therapies, including antibody drug conjugates (ADCs), which are changing the landscape of cancer treatments, said the developer.
They are a critical element of such targeted therapies due to their extremely effective cell-killing abilities at low doses, resulting in reduced side effects for patients.
Dirk Lange, head of life science services at Merck, said: “Increasing capacity at our state-of-the-art CDMO facility in Verona, Wisconsin will allow us to meet the need for these key cancer treatment components.”
Occupational exposure limit
Merck has been developing multi-step, complex, and highly potent compounds for more than 30 years.
HPAPIs, it said, require specialized handling and manufacturing facilities that protect the safety of employees and their environment, and this expansion positions Merck as one of the largest single digit nanogram occupational exposure limit (OEL) CDMO providers in the world.
HPAPIs are measured with the most potent registering less than 10 nanograms per cubic meter. Single digit nanogram HPAPIs require highly specialized handling, which is reflected by the OEL designation.
Many potential life-saving treatments never make it to market in part due to the specialized handling requirements. The Verona, Wisconsin site was the second facility in the world to be SafeBridge-certified and the company continues to meet these rigorous safety and containment requirements, said the company.
Speeding up ADC development and manufacturing
It was also the first CDMO to manufacture commercially approved ADC drugs in North America, and Merck recently launched new technologies to advance such therapies.
Its ChetoSensar technology looks to advance ADC production by alleviating solubility challenges, while its new DOLCORE platform is designed to significantly reduce the development and manufacturing time required.