ApiJect Systems, Corp., a medical technology company, has been approved by the U.S. International Development Finance Corporation for a $590 million 10-year loan to construct a 1-million-square-foot multi-facility Gigafactory in Research Triangle Park, North Carolina.
According to company officials the ApiJect Gigafactory will enable the 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 campus will be home to the world's largest pharmaceutical fill-finish facility, capable of producing annually up to 3 billion single-dose prefilled injectors. The term "fill-finish" commonly refers to the process of converting bulk drug volumes into individual injectable doses.
This new facility brings together the well-established aseptic drug packaging technology known as Blow-Fill-Seal with ApiJect's proprietary pen needle-style hubs to package drugs reliably and safely in BFS prefilled injectors, company officials said. 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.
Jay Walker, ApiJect's Chairman, commented, "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."
The Gigafactory will be Biosafety Level 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.
Franco Negron, CEO of ApiJect, added, "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."
Rich Handler, CEO of Jefferies Financial Group noted the 10-year DFC loan is 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.