Merck announces $65m ADC manufacturing expansion

Completion is expected by mid-2022 and should add approximately 50 full-time jobs starting in 2021

Merck has announced a $65 million (€59m) expansion of its HPAPI and ADC manufacturing capabilities and capacity at its facility near Madison, Wisconsin, USA.

The investment will allow large-scale manufacturing of increasingly potent compounds for therapies that have the potential to treat cancer.

“ADCs have posted incredible growth over the last decade, and regulatory agencies’ approval in recent years demonstrate their promise as a targeted therapy,” said Andrew Bulpin, Head of Process Solutions, Life Science, at Merck.

“With more than 35 years of experience in this space, we have been a frontrunner in the development and manufacturing of biologics, conjugation processes and small molecules. This investment underscores our commitment to working with innovators to bring new treatments to patients quickly and more efficiently.”

The 6,500 sqm commercial building will be a dedicated HPAPI manufacturing facility specifically designed to handle single digit nanogram occupational exposure limit materials.

The project is in addition to the company's campus in St. Louis, Missouri, USA which was the first commercial ADC facility in North America, and 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 only nine ADCs approved globally, but the industry is delivering strong growth and is expected to reach $15.3 (€13) billion by 2030.

While ADCs can provide many benefits compared with other therapeutic options, they also present challenges. Development is complex, necessitating stringent containment infrastructure, and their structural exceptionality requires expertise in different technologies for small and large molecules, as well as analytical capabilities. Owing to these challenges, more than 70% of ADC projects are outsourced to contract development and manufacturing organizations.

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