To aid in the domestic response to the COVID-19 pandemic, the U.S. International Development Finance Corporation (DFC) has approved a $590 million loan to help ApiJect Systems, Corp. build a one million-square-foot multi-facility campus at the edge of Research Triangle Park in Durham, NC. The Connecticut-based company will manufacture its experimental injection device for the mass delivery of vaccines at the new ApiJect Gigafactory, which will employ approximately 650 workers.
The loan will help ApiJect deliver a projected annual capacity of up to three billion vaccine doses, a monthly capacity equal to the full U.S. population coverage. The facility will be able to handle 15 different drugs, vaccines, and therapeutics at the same time, including almost all leading COVID-19 candidates. Additionally, ApiJect will have the ability to switch production quickly, allowing the company to produce in mass quantities and rapidly change to more effective or efficient vaccines as needed.
The project marks the first approved loan under new authority delegated by President Trump under the Defense Production Act (DPA) that enables DFC and the U.S. Department of Defense (DoD) to collaborate in support of the domestic response to COVID-19.
This new facility brings together the aseptic drug packaging technology known as Blow-Fill-Seal (BFS) with ApiJect’s proprietary pen needle-style hubs to package drugs reliably and safely in BFS prefilled injectors. BFS uses pharmaceutical-grade plastic resin to create, fill and seal a strip of 12-25 drug containers per production line every three seconds in a single, highly efficient process.
The Gigafactory will be Biosafety Level 2 (BSL-2) capable and support vaccine candidates that require standard cold storage or ultra-cold storage down to -70 degrees Celsius. Each manufacturing line will be isolated, allowing for up to 15 different drugs to be packaged simultaneously. In addition to its BFS production lines, the ApiJect campus will house two separate special-purpose drug manufacturing facilities to handle drugs such as the next generation of antibiotics and cytotoxic drugs, plus an onsite needle and cannula factory to ensure a domestic supply of this important medical supply chain item.
This new Gigafactory will be the second manufacturing capability developed by ApiJect using BFS technology. Working with a partner company, The Ritedose Corporation (TRC), based in Columbia, SC, and supported by a joint DoD/HHS $138 million contract, ApiJect has repurposed and upgraded, as part of the federal government’s Operation Warp Speed, a BFS manufacturing facility at TRC to have the capacity to aseptically fill and finish up to 45 million doses per month of vaccines and other injectable medicines.
“The DFC loan, along with our close working relationship with the DoD and HHS Assistant Secretary for Preparedness and Response, gives us the ability to move rapidly to support America’s need to re-shore domestically a high volume, high-speed fill-finish capacity for vaccines and other injectable medicines, as well as a needle hub facility,” said Jay Walker, ApiJect’s Chairman.
“The DFC loan enables us to transition as quickly as possible from the emergency short-term program of 45 million a month of dose capacity created under Operation Warp Speed to the Gigafactory’s projected capacity of 250 million doses a month,” said Franco Negron, CEO of ApiJect. “With the Gigafactory, America will have a BSL-2 facility with the flexibility to package up to 15 different drugs simultaneously, and a supply chain sourced 100% in the U.S. This project will ensure America is never caught short in its ability to fill and finish vaccines and injectable medicines necessary to respond to population-wide health threats ranging from COVID-19 to any potential future bio-emergencies.
“Our team at ApiJect worked tirelessly for months on the planning and development necessary to go as quickly and efficiently as possible from groundbreaking to full operation,” Negron added. “Our 185-acre campus at Research Triangle Park (RTP), in North Carolina’s Raleigh/Durham community was selected after a nationwide search of outstanding potential sites and communities for our first multi-purpose campus location. In the end, RTP is a community with a strong pharmaceutical presence, a highly skilled workforce, and ready access to regional and nationwide transportation networks, among a long list of positives.”
In keeping with ApiJect’s commitment to be an industrial resource for U.S. emergency response, the U.S. Government has the right to reserve as many of the Gigafactory’s lines as may be necessary to respond to any national health emergency, such as the COVID-19 pandemic or any similar future event. The Gigafactory will also fill and finish other critical life-saving injectable medicines and vaccines for commercial pharmaceutical clients when not devoted to providing products for national health security.
“By utilizing DFC’s authority under the DPA, our investment in ApiJect will serve as a huge step forward in our fight against this global pandemic,” said DFC Chief Executive Officer Adam Boehler. “ApiJect is currently working with vaccine creators to expedite the delivery of a critical weapon in the fight against COVID-19. Our collaboration with ApiJect will play a key role in enhancing the health and safety of Americans.”
ApiJect anticipates this project will also facilitate the reshoring of critical drug types after COVID-19 demand is met, producing up to 20% of total U.S. consumption of the next generation of antibiotics and cytotoxic drugs. In addition to the DFC loan, significant private investment will support the construction of a high-quality needle hub facility which will substantially reduce ApiJect’s reliance on foreign supply chains.
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