A Connecticut-based medical supplier is spending nearly $900 million to build a North Carolina factory that will make plastic packaging for COVID-19 vaccines.
The ApiJect Systems Corp. plant in Research Triangle Park, N.C., will include 15 blow-fill-seal lines, enough to mold 3 billion single-dose pre-filled injectors annually.
"This project will ensure America is never caught short in its ability to fill and finish vaccines and injectable medicines necessary to respond to populationwide health threats ranging from COVID-19 to any potential future bioemergencies," CEO Franco Negron said in a news release.
ApiJect will receive a $590 million loan from the U.S. International Development Finance Corp. to build the 1 million-square-foot campus called the ApiJect Gigafactory, the company announced Nov. 19.
The single-dose pre-filled injectors will be Biosafety Level 2 (BSL-2) capable, suitable for vaccines requiring ultracold storage down to -70° C (-94° F).
The new facility will incorporate blow-fill-seal aseptic packaging technology with ApiJect's proprietary pen needle-style hubs to package drugs in the pre-filled injectors. A BFS line can blow mold, fill and seal a strip of 12-25 drug containers every three seconds.
Company spokesman Steven Hofman said land is currently being cleared for the new factory, which is scheduled to start production in the first quarter of 2022.
"In subsequent months more of the plant's capabilities will come online," Hofman said. The investment also includes $200 million in private capital and $75 million in pre-ordered machines through a grant from the U.S. departments of Defense and Health and Human Services.
Each manufacturing line will be isolated, allowing up to 15 different drugs to be packaged simultaneously.
The new ApiJect campus also will house two separate special-purpose drug manufacturing facilities to handle drugs including antibiotics and cytotoxic drugs, and an on-site needle and cannula factory.
The factory is ApiJect's second blow-fill-seal project. Earlier in 2020, ApiJect worked with Columbia, S.C.-based Ritedose Corp. to repurpose and upgrade a BFS manufacturing facility to give it the capacity to supply 45 million doses per month. That project was supported by a $138 million joint DOD/HHS contract.
"We have three lines there that are now up and running," Hofman said. "We will get those lines qualified for COVID vaccines. The goal is to be part of the sort of populationwide effort that is likely to come together around April or May of next year."
At the North Carolina Gigafactory, he added, ApiJect will take "the technology that is behind the South Carolina effort and creating 15 unique BFS lines."
In addition to reshoring these supply chains, Hofman said, the factory will "give the U.S. an export capability as well."
"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 reshore 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 said in the release.