11 September 2020 | News
Creates one of the largest single-digit nanogram containment manufacturing facilities for HPAPI production
Image source: PR Newswire
Merck has announced a € 59 million expansion of its Highly potent active pharmaceutical ingredients (HPAPI) and Antibody-drug Conjugates (ADC) manufacturing capabilities and capacity at its facility near Madison, Wisconsin, USA. This investment will allow large-scale manufacturing of increasingly potent compounds for therapies that have the potential to treat cancer. Completion is expected by mid-2022 and should add approximately 50 full-time jobs starting in 2021.
Merck's new 6,500-square-meter commercial building will be one of the largest dedicated HPAPI manufacturing facilities specifically designed to handle single-digit nanogram occupational exposure limit materials.
The project is an addition to the company's Madison campus, which was the first commercial ADC facility in North America designed to handle highly active materials. The new building will join Merck's established campus in St. Louis, Missouri, USA, which specializes in ADC bio-conjugation, active pharmaceutical ingredients, excipient and adjuvants manufacturing.
ADCs are an emerging class of medicines designed for high-specificity targeting and destruction of cancer cells while preserving healthy cells. There are now only nine ADCs approved globally.
The development of ADC’s is complex, necessitating stringent containment infrastructure, and their structural exceptionality requires expertise in a number of different technologies for small and large molecules, as well as analytical capabilities.
The company's comprehensive service portfolio combines the steps of drug development and production - from pre-clinical to commercial - from a single source. This consolidation helps reduce risk and streamlines the process of getting therapies to patients faster.