The expansion, which doubles the production of the highly potent active pharmaceutical ingredients (HPAPIs), builds on Merck’s 30 years of CDMO experience in multi-step, complex, and highly potent compounds


Merck has doubled its HPAPI production capacity. (Credit: PRNewswire/Merck)

Merck has announced the expansion of its manufacturing site in Verona, near Madison, Wisconsin, US, with a new 70,000ft2 CDMO facility, involving a €59m investment.

The expansion is said to double the company’s high-potent active pharmaceutical ingredients (HPAPI) production capacity and creates 50 new jobs in the region.

According to Merck, HPAPIs form an important component in the development of targeted therapies against cancer.

HPAPIs are highly effective in killing cancer cells at low doses, and their use in novel cancer therapies may result in reduced side effects for patients, said the company.

Merck Life Science Services head Dirk Lange said: “There is an increasing demand for HPAPIs due to their effectiveness against cancer at lower doses and the trend towards more targeted therapeutics.

“Lower doses of these therapies reduce the negative side effects for patients who are taking on this critical fight.

“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.”

Handling and manufacturing of HPAPIs require specialised infrastructure to ensure the safety of professionals and their environment.

Also, the specialised handling requirements prevent many potential life-saving treatments from entering the markets, said Merck.

The company claimed that its Verona, Wisconsin site is the world’s second such facility to be SafeBridge-certified and meets stringent safety and containment requirements.

In addition, the current expansion strengthens its position as one of the world’s largest single-digit nanogram occupational exposure limit (OEL) CDMO providers.

HPAPIs are measured with the most potent registering, less than 10ng/m3, and single-digit nanogram HPAPIs need highly specialised handling, indicated by OEL designation.

Merck has been developing multi-step, complex, and highly potent compounds for more than 30 years and continues to develop and manufacture these components.

In addition to HPAPI production, the company is experienced in developing and manufacturing Antibody Drug Conjugates (ADCs).