The U.S. Department of Defense (DoD), on behalf of and in coordination with the U.S. Department of Health and Human Services, has awarded industry partner MilliporeSigma a $136.7M contract award for the construction of a nitrocellulose membrane production facility over a three-year period at the company’s Sheboygan, Wisconsin site. The deal is part of an effort to ensure secure local supply and production capacity for critical products for pandemic preparedness.
DoD and MilliporeSigma, the U.S. and Canada Life Science business of Merck KGaA, Darmstadt, Germany, a leading science and technology company, announced the award on December 29, 2021. The DoD’s Defense Assisted Acquisition Cell (DA2) led this effort in coordination with the Department of the Air Force’s Acquisition COVID-19 Task Force (DAF ACT). This effort was funded through the American Rescue Plan Act (ARPA) to support domestic industrial base expansion for critical medical resources.
Nitrocellulose membrane, also called lateral flow membrane, is a critical material used in manufacturing SARS-CoV-2 rapid point-of-care tests. This industrial base expansion effort will support the production of more than 83.3 million tests per month for COVID-19 testing and future needs.
“With this agreement, MilliporeSigma will construct a state-of-the-art lateral flow membrane production facility that will give our in vitro diagnostic (IVD) manufacturing customers greater flexibility and security of supply of our Hi-Flow™ Plus lateral flow membranes,” said Matthias Heinzel, Member of the Executive Board and CEO, Life Science, Merck KGaA, Darmstadt, Germany.
“Our lateral flow membranes have earned a reputation for high consistency among rapid diagnostic manufacturers and the already robust demand for this membrane has significantly increased since the onset of the pandemic. With this critical investment, we are expanding much-needed access to essential diagnostic testing as a trusted partner to the world’s most sophisticated diagnostic manufacturers,” said Jean-Charles Wirth, head of Applied Solutions, Life Science.
Building this new facility supports the overall Life Science business sector’s strategy to add physical capacity and expand its regional network to enable further growth of its key portfolios.
The Hi-Flow™ Plus Lateral flow membrane is used in rapid diagnostic test kit manufacturing by the Life Science business’ customers, enabling reproducible results due to its consistent quality and optimized properties. The rapid test kits are used for a variety of applications, including Infectious Disease testing (COVID-19, HIV, influenza, malaria, etc.), as well as in women’s health, biomarker detection, drug testing, food safety and animal health. Due to continuously increasing demand for lateral flow membrane, the Life Science business had already invested in a second membrane casting line in Cork, Ireland, which was recently completed, and expanded the range of other critical reagents (antibodies, beads, blockers, buffers) utilized to develop lateral flow rapid test kits. These strategic investments position the Life Science business as an important critical raw material supplier for the Diagnostic market, especially as the company prepares for IVD Regulation and Medical Device Regulation.
The Life Science business is undertaking an ambitious, multi-year program to increase production capacity and capabilities to support the growing global demand for lifesaving vaccines, therapies and diagnostics. Within the last year, the company has accelerated investments to expand capacity to produce its support Mobius® single-use assemblies in both the U.S. and France, as well as increased capacity for the production of cell culture media in the U.S. and UK, among others. Additionally, several expansion projects continue to advance across the company’s manufacturing and distribution global network.