MilliporeSigma Announces Expansion of Stable Isotope Center of Excellence in Miamisburg, Ohio
News Release
- 50%+ increase in production capacity of Urea-13C, a key API used in test kits to detect bacteria related to stomach disease
- Represents continued commitment to advancing Stable Isotopes business for diagnostic, industrial and research applications
Burlington, MA, January 11, 2022 – MilliporeSigma, the U.S. and Canada Life Science business of Merck KGaA, Darmstadt Germany, a leading science and technology company, today announced the expansion of its Stable Isotope Center of Excellence in Miamisburg, Ohio. The expansion reinforces the company’s continued commitment to this category of products, which demonstrate growing utility in key diagnostic, industrial and research applications. The new infrastructure increases production capacity of the GMP-grade urea-13C Active Pharmaceutical Ingredient (API) used by Urea-13C Breath Test (UBT) kit manufacturers by more than 50%.
“As a key hub for Urea-13C production, the expansion at our Stable Isotope Center of Excellence represents an important advancement in supplying this active ingredient for kits used to diagnose stomach ulcers and certain types of stomach cancer. Investing in advancing and accelerating the base for such innovation, as well as offering regulatory support to our customers, is key to meet growing global demand,” said Klaus-Reinhard Bischoff, head of Research Solutions, Life Science business sector at Merck KGaA, Darmstadt, Germany.
The Urea-13C Breath Test is a simplified way to detect Helicobacter pylori, a type of bacteria that has been linked to the development of such diseases. While other techniques such as histology, microbiological culture, and polymerase chain reaction tests rely on endoscopy, the Urea-13C Breath Test is a non-invasive test. Unlike the Urea-14C Breath Test, it is based on the non-radioactive Carbon-13 stable isotope. The Urea-13C Breath Test can be used in routine clinical environments, such as clinics and physicians' offices, detecting only active infection for a more accurate diagnosis.
Current research in cancer diagnostics and treatment monitoring, trauma detection, and in metabolic pathway mapping may give rise to new applications for 13C-based diagnostic agents.
About the Life Science business of Merck KGaA, Darmstadt, Germany
The Life Science business of Merck KGaA, Darmstadt, Germany, which operates as MilliporeSigma in the U.S. and Canada, has more than 23,000 employees and 59 manufacturing sites worldwide, with a portfolio of more than 300,000 products focused on scientific discovery, biomanufacturing and testing services. Merck KGaA, Darmstadt, Germany, a leading science and technology company, operates across healthcare, life science and electronics.
Around 58,000 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 2020, Merck KGaA, Darmstadt, Germany generated sales of € 17.5 billion in 66 countries.
The company holds the global rights to the name and trademark “Merck” internationally. The only exceptions are the United States and Canada, where the business sectors of Merck KGaA, Darmstadt, Germany operate as EMD Serono in healthcare, MilliporeSigma in life science, and EMD Electronics. Since its founding 1668, scientific exploration and responsible entrepreneurship have been key to the company’s technological and scientific advances. To this day, the founding family remains the majority owner of the publicly listed company. For more information about Merck KGaA, Darmstadt, Germany, visit www.emdgroup.com.
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