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MilliporeSigma Breaks Ground on U.S. Production Facility

New facility to manufacture Hi-Flow Plus lateral flow membrane used in rapid diagnostic test kit manufacturing, including Covid-19.

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By: Tim Wright

Editor-in-Chief, Contract Pharma

MilliporeSigma, the U.S. and Canada Life Science business of Merck KGaA, broke ground at its Sheboygan, WI site, for the company’s first lateral flow membrane production facility in the U.S. Lateral flow membranes are a key component in rapid diagnostic test kits for a variety of applications, including Covid-19 testing. The new facility is supported by a $136.7 million contract award from the U.S. Department of Defense (DoD), on behalf of the U.S. Department of Health and Human Services.

“Our purpose is to positively impact life and health with science, and today’s ground-breaking exemplifies this commitment by adding physical capacity and expanding our regional network to meet the growing needs of our customers and ensure supply chain security,” said Matthias Heinzel, member of the executive board of Merck KGaA and CEO life science. “This new, state-of-the-art facility will support the surge in demand experienced by our global in-vitro diagnostic manufacturing customers.”

Wisconsin Governor, Tony Evers, said, “From COVID-19 rapid testing to cancer therapies, the work MilliporeSigma does helps promote the health and safety of our families and communities while creating good jobs for hardworking Wisconsinites, and I am glad to be celebrating their success today. In addition to creating 60 new jobs in Sheboygan, this new facility will provide a major step forward in expanding domestic diagnostic testing as the company’s first lateral flow membrane production facility in the U.S., ensuring our state and country are ready to tackle any public health crisis that comes our way now and into the future.”

Once built, the lateral flow membrane facility will be MilliporeSigma’s first facility in the U.S. capable of producing diagnostic-grade membrane. Its location further supports the company’s competitive market advantage with improved supply security and reduced lead times for global customers. The lateral flow membrane production line in Sheboygan complements the global capacity network of the Life Science business sector of Merck KGaA, Darmstadt, Germany, by adding redundant capabilities to its two production lines in Cork, Ireland, thereby mitigating supply chain risks.

“This new facility will expand much-needed access of critical raw materials to the world’s most sophisticated diagnostic manufacturers. Our best-in-class lateral flow membranes provide the quality and consistency necessary as manufacturers prepare for new regulations for in-vitro diagnostics and medical devices,” said Jean-Charles Wirth, head of science and lab solutions, life science business of Merck KGaA.

Hi-Flow Plus Lateral flow membrane enables reproducible results due to its consistent quality and optimized properties. The rapid point-of-care test kits developed by the company’s customers are used for a variety of applications, including infectious disease testing (e.g., Covid-19, HIV, influenza, malaria), as well as in pregnancy testing, biomarker detection, drug testing, food safety and animal health.

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