March 18, 2020
HHS Announces New Public-Private Partnership to Develop U.S.-Based, High-Speed Emergency Drug Packaging Solutions
The U.S. Department of Health and Human Services (HHS) has launched a public-private partnership to create a U.S.-based, high-speed, high-volume emergency drug packaging solution using low-cost prefilled syringes.
Working with HHS' Office of the Assistant Secretary for Preparedness and Response (ASPR), the new consortium for Rapid Aseptic Packaging of Injectable Drugs, or RAPID, will enable the Strategic National Stockpile (SNS) to fill and finish, on a rapid basis, hundreds of millions of prefilled syringes to respond quickly and efficiently to widespread health emergencies, such as the novel coronavirus outbreak. Projects are under evaluation to expedite this process and could yield results within six months.
"The ability to deliver vaccines and therapeutic drugs when they are needed the most is among our top priorities. As vaccines and therapeutics become available, we must not be caught short on our capacity to deliver emergency drugs to Americans in need," said HHS Secretary Alex Azar. "The creation of RAPID is the right move at the right time, both for immediate and longer-term national public health emergency needs."
The RAPID consortium is being launched to build a surge capacity network of up to eight domestic facilities for the manufacture of prefilled syringes using a well-established process called Blow-Fill-Seal (BFS). The BFS process features a low cost, high volume, sterile plastic container that holds a pre-filled volume of medicines. This technology is already used for the delivery of billions of doses annually of sterile medicines such as eye drops, nasal sprays, and rotavirus oral vaccines. The RAPID consortium will combine well-established BFS technology with an innovative interlocking needle hub that eliminates the inefficiencies and difficulties of drawing medicines from glass vials. This will help the SNS to reduce its reliance on existing glass vial manufacturing and filling technology with very limited surge capacity.
HHS Assistant Secretary for Preparedness and Response Robert Kadlec commented, "We have been working over the past year on the creation of the RAPID consortium as an essential element of our nation's ability to deliver medicines quickly to large and wide-spread populations affected by a health emergency."
ASPR awarded Apiject Systems America, the public benefit corporation leading RAPID, with an award valued up to $456 million for research and development of BFS prefilled syringes, rapid prototyping and stability testing of select medical countermeasures from the SNS in these devices. Apiject Systems America will recruit the private and philanthropic investment necessary to create year-round domestic manufacturing facilities of aseptic BFS prefilled syringes for population-scale surge response capacity during health emergencies.
About HHS, ASPR and SNS
HHS works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. The mission of ASPR is to save lives and protect Americans from 21st century health security threats. ASPR leads the federal government's healthcare and public health preparedness, response, and recovery efforts.
The SNS is the nation's largest supply of potentially life-saving pharmaceuticals and medical supplies for use in a public health emergency severe enough to cause local supplies to run out. When state, local, tribal, and territorial responders request federal assistance to support their response efforts, the stockpile ensures that the right medicines and supplies get to those who need them most during an emergency. Organized for scalable response to a variety of public health threats, this repository contains enough supplies to respond to multiple large-scale emergencies simultaneously.