The U.S. Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response (HHS/ASPR) today announced support for development of a high-speed manufacturing line to produce N95 respirators to meet surges during a pandemic event.
Halyard Health Inc., formerly Kimberly-Clark Health Care, has been awarded a contract by the Biomedical Advanced Research and Development Authority (BARDA), part of HHS/ASPR, to develop a one-of-a-kind, high-speed machine for rapid manufacture of N95 Filtering Facepiece Respirators (FFRs).
These types of respirators are used in health care settings to prevent the transmission of microorganisms through airborne particles. Development of the high-speed manufacturing line will take place under a 14-month, $1.6 million contract, which can be extended for two years and $5 million.
U.S. manufacturing companies currently can produce up to about 150,000 respirators per day on a single machine. However, an analysis by the Institute of Medicine conducted in 2006 estimated that during a pandemic, at least 90 million respirators would be needed in a 42-day period to treat influenza patients safely in U.S. health care settings.
“Pandemic preparedness in the United States is imperative to protecting health and saving lives, and respirator manufacturing capacity remains a critical gap in that preparedness,” BARDA Director Robin Robinson, Ph.D., said. “Innovations in manufacturing like this high-speed line can help bridge that gap and by applying innovative approaches to manufacturing day-to-day, we improve readiness.”
Through the new BARDA-supported project, Halyard Health will research and test manufacturing processes, core manufacturing components, and design a new manufacturing line capable of functioning at high speeds to allow for greater surge capacity and rapid availability during a pandemic. If successful, the technology could be available to replace outdated and slow machines with high-speed machines that can produce between one and two million N95 respirators in one day.
“Halyard is pleased to have been selected by HHS to try to help solve this real problem,” said Lee Burnes, vice president, research and development at Halyard. “All government agencies agree that a shortage of respirators will occur during a pandemic. So, we have a real opportunity to demonstrate our expertise and help make a difference in an area of critical need by performing research on the ability to develop an on-demand, high-speed machine that will make use of stockpiled raw materials to produce respirators.”
The effort will improve and expand medical countermeasure manufacturing capabilities for the U.S. that will result in a cost-effective approach for mitigating the projected shortages of the most commonly used FFRs – that protect healthcare workers from both droplet and aerosol transmission of infections during a pandemic.
BARDA is seeking additional proposals for advanced development of new drugs and products to diagnose, prevent, treat, and protect health against influenza viruses with pandemic potential. Proposals are accepted through the Broad Agency Announcement BAA-16-100-SOL-00002.