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Apiject was approved for a $590-million loan from the US to build in-country capacity for COVID-19 vaccines and therapeutics.
ApiJect Systems, a public benefit corporation based in Connecticut, announced on Nov. 19, 2020 that it has been approved by the US International Development Finance Corporation (DFC) for a $590 million loan to construct a multi-facility campus for fill/finish of injectable medicines and vaccines in the event of a national emergency, beginning with COVID-19.
The one million-ft2 campus will be located in Research Triangle Park, NC. The company intends to build a facility, which it is calling the Gigafactory, to package up to three billion single-dose prefilled injectors annually using blow-fill-seal (BFS) technology using ApiJect's proprietary pen needle-style hubs. The factory will be Biosafety Level 2 (BSL-2) capable and support vaccine candidates that require standard cold storage or ultra-cold storage down to -70 °C. By isolating each manufacturing line, up to 15 different drugs can be packaged simultaneously.
The new ApiJect campus will also include two drug manufacturing facilities to handle drugs such as the next generation of antibiotics and cytotoxic drugs. The campus will also have a needle and cannula factory.
ApiJect currently has a BFS facility, with a partner company, The Ritedose Corporation (TRC), based in Columbia, SC. As part of the US Operation Warp Speed, ApiJect repurposed and upgraded the 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 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. “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."
According to the press release, the US government has the right to reserve as many of the Gigafactory's lines as may be necessary to respond to any national health emergency. The facility 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.