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CT-based company to manufacture single-use vaccine syringes near RTP

ApiJect, the maker of an experimental injection device for mass vaccine delivery, is planning a huge expansion at the edge of Research Triangle Park in Durham, the company said Thursday.

ApiJect has announced plans to build a 1 million square foot factory where it will manufacture its devices. The project could employ around 650 people.

The Connecticut-based company’s devices have yet to gain approval from the U.S. Food and Drug Administration. But on Thursday, he said that a federal government agency, the US International Development Finance Corp., had approved the company for a $ 590 million loan to build the facility.

The loan was billed as a way to help the United States deliver vaccines and medicine faster in a national emergency – in this case, the COVID-19 pandemic.

With positive test results reported by potential COVID-19 vaccine manufacturers Pfizer and Moderna, the nation faces a potentially difficult vaccine rollout for millions of Americans.

Apiject campus.jpg
An artist rendering of the ApiJect Gigafactory installation which will be located in the Research Triangle Park in North Carolina. ApiJect

If approved, Pfizer and Moderna said they would be able to deliver tens of millions of vaccines by the end of the year, likely for frontline healthcare workers. But, by 2021, hundreds of millions of doses will be needed in the United States – and even more internationally.

When completed, the RTP facility would be able to manufacture up to 3 billion single-dose pre-filled injectors per year by 2022, the company said. ApiJect expects the complete construction to cost nearly $ 900 million.

A spokesperson for the company, Steven Hoffman, said in a telephone interview that North Carolina was chosen after a nationwide search for suitable locations. The facility is expected to be located at 2501 East Cornwallis Road in Durham, near where Eli Lilly is also building a large manufacturing plant.

Franco Negron, CEO of ApiJect, said the loan will help the company move to a capacity of 250 million doses per month as quickly as possible. Negron called the Durham facility a “Gigafactory”.

“With the Gigafactory, America will have a facility with the ability to package up to 15 different drugs simultaneously and a supply chain 100% sourced from the United States,” he said. in a press release. “This project will ensure America is never caught short in its ability to fill and complete the vaccines and injectables needed to respond to population-wide health threats ranging from COVID-19 to any potential future bio-emergencies. “

Negron added that the company chose RTP because it has a “strong pharmaceutical presence, a highly skilled workforce and easy access to regional and national transportation networks.”

ApiJect pre-filled injector - Complete with Cap.jpg
The ApiJect pre-filled injector that will be manufactured in their planned RTP factory. Apiject

Tony Copeland, North Carolina Secretary of Commerce, said ApiJect had not contacted the state to request incentives for the project.

He said the expansion had really been made possible because of the large amount of federal money being distributed in response to the pandemic.

“These are not normal times,” he said. “The amount of money coming out of Washington changes the paradigm.”

But he said he believed North Carolina’s previous investments in pharmaceutical manufacturing operations had prepared the state to be the winner of this expansion. In recent years, the Triangle has landed manufacturing expansions from companies like Eli Lilly, Corning, and Merck, among others.

“Every additional investment we get in life sciences creates a larger ecosystem and creates more [opportunities]”said Copeland.

In the meantime, the company has contracted with Ritedose Corp. of Columbia to reassign a facility in South Carolina. When reused, it could have the capacity to fill up to 45 million doses per month of vaccines and other injectable drugs by next year, ApiJect said. This is funded through a Department of Defense contract worth $ 138 million.

The federal loan for the RTP facility has a term of 10 years, with an interest rate of around 4.5%, ApiJect said. Under the terms of the loan, ApiJect will need to raise an additional $ 195 million in capital to complete the installation, none of which may come from government sources.

This story was produced with the financial support of a coalition of partners led by Innovate Raleigh as part of an independent journalism scholarship program. The N&O retains full editorial control of the work. Learn more; go to bit.ly/newsinnover

This story was originally published 19 November 2020 12:15 pm.

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Zachery Eanes is the Innovate Raleigh reporter for The News & Observer and The Herald-Sun. It covers technology, startups and large companies, biotechnology and education issues related to these fields.

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Margarita W. Wilson

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