HPAPI and ADC manufacturing facility, Merck KGaA, Wisconsin, USA

Darmstadt headquartered Merck KGaA, a leading science and technology company operating in the U.S. & Canada as MilliporeSigma, has announced a major expansion of its HPAPI and ADC manufacturing capabilities and capacity at its manufacturing facility near Madison, Wisconsin, USA.

The antibody-drug conjugate manufacturing expansion is said to create one of the largest single-digit nanogram containment manufacturing facilities for high-potent active pharmaceutical ingredient (HPAPI) production.

A € 59 million investment in HPAPI and ADC production

Merck’s investment of € 59 million is planned to allow large-scale manufacturing of increasingly potent compounds for therapies that have the potential to treat cancer. Completion of the project is expected by mid-2022 and should open up around 50 new full-time jobs starting in 2021.

Andrew Bulpin, head of Process Solutions, Life Science, at Merck commented:

“ADCs have posted incredible growth over the last decade, and regulatory agencies’ approval in recent years demonstrate their promise as a targeted therapy. 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 largest HPAPI and ADC manufacturing facility

The new 6,500-square-meter commercial building will be one of the largest dedicated HPAPI manufacturing facilities in the world, specifically designed to handle single-digit nanogram occupational exposure limit materials. The ambitious project is an addition to the Merck’s Madison campus, which was the first commercial ADC facility in North America designed and constructed to handle highly active materials.

The new manufacturing facility will become a new addition to Merck’s already well-established campus in St. Louis, Missouri, USA, specialising in ADC bio-conjugation, active pharmaceutical ingredients (API’s), excipient and adjuvants manufacturing.

Investing in ADC’s

ADCs are an emerging class of medicines designed for high-specificity targeting and destruction of cancer cells while preserving healthy cells. Currently, there are only nine ADCs approved globally. However, the company has made a strategic investment with a recent market analysis conducted by the European Pharmaceutical Review, showing that the ADC industry is delivering strong growth and is expected to reach € 13 billion by 2031.

Whilst ADCs can offer numerous benefits compared to other therapeutic options, they also present a unique set of challenges. The development of ADCs 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. Due to these challenges, more than 70 per cent of ADC projects are outsourced to contract development and manufacturing organisations (CDMOs).

Merck’s expertise in clinical and commercial manufacturing

With more than 35 years of experience in the development and manufacturing of small molecules, biologics and ADC technologies, Merck offers extensive experience in both clinical and commercial manufacturing. 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 to minimise the risks and streamlines the process of getting therapies to patients faster.