As a number of COVID-19 vaccines rush to the regulatory finish line, the US government seeks to solidify its filling prospects with massive investment in Stamford, Connecticut’s ApiJect Systems, maker of a plastic injector pre-filled designed for nation of its usual glass vial and syringe.
ApiJect was approved Thursday by the American International Development Finance Corporation (DFC) for a $ 590 million loan to increase the capacity of its single-dose prefilled injectors to 3 billion devices per year. The money will fund the construction of a multi-facility campus in Triangle Park, North Carolina, designed to speed up the process of packaging high volumes of injectable drugs and vaccines for a national emergency, starting with the pandemic of COVID-19, the company said. in one Release (PDF).
The 1,000,000 square foot campus will house the so-called “ApiJect Gigafactory”, which is expected to feature “the world’s largest pharmaceutical filling and finishing facility”, with a capacity of approximately 250 million doses per month, a declared ApiJect.
The facility aims to combine the aseptic drug packaging technology known as blow-fill-seal (BFS) with ApijJect’s proprietary needle-to-pen style hubs to quickly package drugs and vaccines into injectors. pre-filled BFS from the company. The process uses pharmaceutical grade plastic resin to create, fill and seal a strip of 12 to 25 drug containers per production line every three seconds, ApiJect said.
The Gigafactory would be able to handle vaccines requiring standard cold storage, as well as those requiring ultra-cold storage down to -70 degrees Celsius (-94 degrees Fahrenheit) – the temperature necessary to keep the hopes of Pfizer and BioNTech’s mRNA-based vaccine, BNT162b2, stable. ApiJect said it further plans to isolate each manufacturing line, allowing up to 15 different drugs to be packaged simultaneously.
Beyond the fill-finish lines, the campus will also house two special-purpose drug manufacturing facilities, intended to produce the next generation of antibiotics and cytotoxic drugs, as well as an on-site factory for the production of needles and cannulas, tubes inserted into the body. to drain or deliver fluids, the company said.
This latest cash injection complements ApiJect’s previous $ 138 million contract with the US Department of Defense and Department of Health and Human Services to increase its production of injectors under the Operation vaccine program. The Trump Administration’s Warp Speed. This agreement, inked in may, saw ApiJect partner with The Ritedose Corporation (TRC), based in Columbia, South Carolina, to reassign and upgrade a TRC facility to support fill and finish capacity up to 45 million doses of drugs or vaccines per month.
The loan of more than half a billion is not without its criticisms, however. ApiJect’s injection device, intended to provide an alternative to traditional glass vials and syringes, is still awaiting FDA approval. Although it is a good idea to have a backup plan for glass vials, already reported to be in low supply earlier this year – that the government is investing so heavily in unproven technology is of concern, Nicole Lurie, strategic advisor to the Coalition for Epidemic Preparedness Innovations and former deputy secretary for preparedness and response to the Ministry of Health and Social Services, Told NPR.
“The challenge I see is that this is totally untested technology, and I don’t know what types of conversations ApiJect has had with the FDA or any other regulator,” Lurie said. “What tests have been done to ensure that the materials inside the containers do not interact with compounds from various vaccines? They probably need to be tested for every vaccine and in particular every vaccine platform.”
ApiJect’s technology has been used in the liquid pharmaceutical space for years, but never before for such a vaccine company. Meanwhile, the company has worked with the FDA and is “through all the tough parts,” Jay Walker, executive chairman of ApiJect, told NPR.