New Public-Private Partnership Created to Develop a U.S.-Based High-Speed, Emergency Surge Drug Packaging Solution, Using Mass-Manufacturable Prefilled Syringes with Optional Mobile-Based GPS Tracking and Confirmation.
ApiJect Systems America, a public benefit corporation based here, today joined with the U. S. Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response in announcing the launch of a public-private partnership dedicated to creating a U.S.-based high-speed, high-volume, emergency drug packaging solution, establishing "surge capacity" for mass-manufacturable prefilled syringes.
The new consortium, called RAPID — Rapid Aseptic Packaging of Injectable Drugs — will be created and managed by ApiJect Systems America. Its purpose is to enable the U.S. Strategic National Stockpile (SNS) to fill and finish hundreds of millions of prefilled syringes to respond quickly and effectively to health emergencies such as COVID-19. The RAPID Consortium will build a surge capacity network of up to eight domestic packaging facilities using a well- established, drug-packaging process called Blow-Fill-Seal (BFS).
The BFS process, used in sterile manufacturing facilities worldwide, features a high volume, small medical-grade plastic container that holds a prefilled volume of medicines or vaccines. FDA-approved BFS technology is already used to package billions of doses annually for medicines to treat respiratory conditions, rotavirus oral vaccines and more.
The RAPID Consortium will combine this well-established BFS technology with an innovative interlocking needle hub. The result is a prefilled syringe that eliminates the inefficiencies and difficulties of packaging medicines in, and drawing medicines from, glass vials using disposable syringes.
In addition, each prefilled syringe has the option to include an NFC chip that incorporates a secure unique ID number. This enables healthcare professionals at the point of care to use an app on their smartphones to verify that the drug being injected is authentic and unexpired. It also enables health authorities to know in real time when and where each dose is injected.
ApiJect Systems America CEO Jay Walker commented: "This partnership launched by HHS means we have joined the vital effort to battle our nation's most urgent public health emergency in our lifetime."
Walker continued: "American industry has a long history of rising to the occasion to provide for emergency needs in times of crisis. Our manufacturing sector, virtually overnight, built the tools that enabled us to prevail in World War Two. Our health sector innovated to turn the tide against polio and saved millions of lives from HIV/AIDS.
The need today to deliver emergency therapeutics and an eventual vaccine for COVID-19 or other public health threats is no greater a challenge than those we have responded to in the past. Our partnership with HHS will enable us to ensure that when critical therapeutics and vaccines are available to meet this crisis, the necessary volume of ready-to-use prefilled syringes will be ready to deliver these essential medicines."