- Expansion doubles production of the most highly potent active pharmaceutical 
ingredients (HPAPIs)

- Merck now one of industry's largest manufacturers of these components globally

- Builds on company's 30 years' CDMO experience with multi-step, complex, and 
highly potent compounds


Merck, a leading science and technology company, announced that its Life 
Science business sector has doubled its high-potent active pharmaceutical 
ingredients (HPAPI) production capacity with the expansion of its facility in 
Verona, near Madison, Wisconsin, USA. This new euro59 million, 70,000 square 
foot facility, officially opened today, brings 50 new jobs to the area. 

Photo - https://mma.prnewswire.com/media/1845670/Verona_expansion_image.jpg

"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," said Dirk Lange, head of Life Science 
Services, Life Science, at Merck. "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."

Cancer is the second leading cause of death worldwide[1]. HPAPIs are a critical 
element of targeted therapies due to their extremely effective cell-killing 
abilities at low doses, resulting in reduced side effects for patients. They 
are used in novel cancer therapies, including antibody drug conjugates (ADCs), 
which are changing the landscape of cancer treatments.

Merck has been developing multi-step, complex, and highly potent compounds for 
more than 30 years and continues to be an industry leader in the development 
and manufacture of these components. HPAPIs require specialized handling and 
manufacturing facilities that protect the safety of employees and their 
environment. Many potential life-saving treatments never make it to market in 
part due to the specialized handling requirements. Merck's Verona, Wisconsin 
site was the second facility in the world to be SafeBridge(R)-certified and the 
company continues to meet these rigorous safety and containment requirements 
necessary to this day. In fact, 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.

In addition to HPAPI production, Merck also has extensive experience developing 
and manufacturing ADCs. Being the first CDMO to manufacture commercially 
approved ADC drugs in North America, the company recently launched new 
technologies to advance ADC therapies. Its unique ChetoSensarTM technology 
gives new promise to ADCs by alleviating solubility challenges, and Merck's new 
DOLCORETM platform significantly reduces development and manufacturing time 
required, increasing speed-to-market by up to a year, ultimately getting needed 
therapies to patients quicker.

With more than 30 years of CDMO experience in the development and manufacturing 
of HPAPIs, linkers and mAbs, Merck offers significant expertise in both 
clinical and commercial manufacturing. The company also has extensive CDMO 
experience in viral vector, lipids, LNP and mRNA manufacturing— from 
pre-clinical to commercial — helping to streamline steps of drug development 
and production with a single, highly experienced partner. Additionally, 
BioReliance(R) contract testing services are integrated into the overall 
Services offering to further streamline the development path.

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About Merck

Merck, a leading science and technology company, operates across life science, 
healthcare and electronics. More than 60,000 employees work to make a positive 
difference to millions of people's lives every day by creating more joyful and 
sustainable ways to live. From advancing gene editing technologies and 
discovering unique ways to treat the most challenging diseases to enabling the 
intelligence of devices – the company is everywhere. In 2021, Merck generated 
sales of euro 19.7 billion in 66 countries.

Scientific exploration and responsible entrepreneurship have been key to 
Merck's technological and scientific advances. This is how Merck has thrived 
since its founding in 1668. The founding family remains the majority owner of 
the publicly listed company. Merck holds the global rights to the Merck name 
and brand. The only exceptions are the United States and Canada, where the 
business sectors of Merck operate as MilliporeSigma in life science, EMD Serono 
in healthcare, and EMD Electronics in electronics.

[1] "Global Cancer Facts & Figures 4th Edition, 
https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/global-cancer-facts-and-figures/global-cancer-facts-and-figures-4th-edition.pdf


SOURCE:  Merck

CONTACT: Rachel Bloom Baglin, Phone: +49 6151 72-44461