ApiJect Systems, Corp. says it has been approved by the U.S. International Development Finance Corporation (DFC) for a $590 million loan to construct a vaccine production “gigafactory” in Research Triangle Park.
The factory will allow U.S. to more quickly package high volumes of injectable medicines and vaccines in the event of a national emergency, beginning with COVID-19, the company says in a statement.
The North Carolina factory on a one million sq. ft. campus will feature “the world’s largest pharmaceutical fill-finish facility, capable of producing annually up to 3 billion single-dose prefilled injectors,” the company said on Nov. 19. “The term “fill-finish” commonly refers to the process of converting bulk drug volumes into individual injectable doses.
Site clearing has already begun, along with design planning, Raleigh broadcaster ABC 11 (WTVD-TV) reported. “Groundbreaking is expected to begin by the end of 2020 and will continue through 2021. The first production lines are expected to be ready to commence operations in the first half of 2022. Full operational capacity for the main 15 BFS production lines at the Gigafactory is scheduled for late 2023.”
The company estimates that the project will bring about $300 million in construction-related spending to the area, the published report says.
“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, South Carolina, 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,” ApiJect chairman Jay Walker, ApiJect’s Chairman said in the statement.
Franco Negron, CEO of ApiJect, stated: “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. 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 said. “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.”
The DFC loan will be for 10 years, at an interest rate of approximately 4.5%. Closing of the DFC loan is conditioned on DFC’s completion of due diligence and finalization of financing arrangements. Under the loan’s terms, an additional $195 million of equity to complete the overall campus must come from non-U.S. government sources. Jefferies Financial Group is handling ApiJect’s capital raise.