ApiJect Systems

ApiJect Systems was founded in 2018 by Marc Koska, who invented the ApiJect injector, a prefilled, single-use plastic injector, as a low cost way to get medicine to poorer countries.{{Cite web|title=U.S. Bets On Small, Untested Company to Deliver COVID Vaccine|url=https://www.pbs.org/wgbh/frontline/article/apiject-u-s-bets-on-small-untested-company-deliver-covid-vaccine/|access-date=2021-09-01|website=Frontline|language=en-US}} Koska previously invented the self-locking K1 syringe to prevent needle reuse.{{Cite web|date=2021-03-09|title=4 innovations that found their use case during the pandemic - News|url=https://www.mmm-online.com/home/channel/4-innovations-that-found-the-right-time-during-the-pandemic/|access-date=2021-06-29|website=MM+M - Medical Marketing and Media|language=en-US}}

In 2020, ApiJect pivoted in order to meet U.S. demand for COVID-19 vaccinations. In May 2020, the U.S. Department of Health and Human Services and the U.S. Department of Defense signed a $138 million deal with ApiJect, called Project Jumpstart, to facilitate the production of 100 million prefilled syringes by the end of 2020 and 500 million in 2021 in the event that a COVID-19 vaccine became available.{{Cite web|title=Trump admin to ramp up syringe production for future COVID-19 vaccine|url=https://www.nbcnews.com/news/us-news/trump-admin-unveils-plan-ramp-syringe-production-future-covid-19-n1204436|access-date=2021-06-29|website=NBC News|date=12 May 2020 |language=en}}

In November 2020, ApiJect was approved for a $590 million loan from the U.S. International Development Finance Corporation to construct a multi-facility campus.{{Cite web|title=ApiJect snares $590M government loan for 'Gigafactory' to produce billions of prefilled vaccine injectors per year|url=https://www.fiercepharma.com/drug-delivery/apiject-snares-590m-government-loan-for-gigafactory-to-produce-billions-pre-filled|access-date=2021-06-29|website=FiercePharma|date=20 November 2020 |language=en}} The project broke ground in February 2021 in Durham, North Carolina, and was among the largest projects in the nation to break ground that month.{{Cite web|last=Buckshon|first=Mark|title=$785 million ApiJect Gigafactory in Durham among largest projects in nation to start, despite overall national decline: Dodge |date=17 March 2021 |url=https://www.ncconstructionnews.com/785-million-apiject-gigafactory-in-durham-among-largest-projects-in-nation-to-start-despite-overall-national-decline-dodge/|access-date=2021-06-29|language=en-US}} The factory is designed to deliver production capacity of up to 2 to 3 billion units annually.{{Cite web|date=2021-05-03|title=Special Feature – PFS & Parenteral Manufacturing: How COVID-19 Changed the Market|url=https://drug-dev.com/special-feature-pfs-parenteral-manufacturing-how-covid-19-changed-the-market/|access-date=2021-06-29|website=Drug Development and Delivery|language=en-US}} It will be suitable for vaccines requiring standard cold storage, including those in need of ultra-cold storage down to -70 degrees Celsius.

As of April 21, 2021 the company has failed to produce any syringes,{{Cite web|title=The U.S. awarded a firm $1.3 billion to make syringes. Where are they?|url=https://www.nbcnews.com/health/health-care/trump-administration-awarded-firm-1-3-billion-make-covid-vaccine-n1263872|access-date=2021-04-21|website=NBC News|date=21 April 2021 |language=en}} however it has met its obligations under its federal contracts and loan commitments by lining up a subcontractor that promises to produce the syringes once they obtain FDA approval.{{Cite web|title=The U.S. awarded a firm up to $1.3 billion to make syringes. Where are they?|url=https://www.nbcnews.com/health/health-care/trump-administration-awarded-firm-1-3-billion-make-covid-vaccine-n1263872|access-date=2021-06-29|website=NBC News|date=21 April 2021 |language=en}} The CEO of the company stated in July 2020: "The fact of this matter is, it would be crazy for people to just rely on us...We should be America’s backup at this point, but probably not its primary.”{{Cite web|title=U.S. Bets On Small, Untested Company to Deliver COVID Vaccine|url=https://www.pbs.org/wgbh/frontline/article/apiject-u-s-bets-on-small-untested-company-deliver-covid-vaccine/|access-date=2021-04-21|website=Frontlin|language=en-US}} According to the White House 100 Days report of June 2021, Health and Human Services is planning to expand Project Jumpstart to $250 million per month through 2023.{{Cite web|title=Building Resilient Supply Chains, Revitalizing American Manufacturing, and Fostering Broad-Based Growth|url=https://bidenwhitehouse.archives.gov/wp-content/uploads/2021/06/100-day-supply-chain-review-report.pdf|url-status=live|website=White House|archive-url=https://web.archive.org/web/20210608104604/https://www.whitehouse.gov/wp-content/uploads/2021/06/100-day-supply-chain-review-report.pdf |archive-date=2021-06-08 }}

In December 2021, ApiJect and Fareva announced a licensing agreement to establish three Blow-Fill-Seal manufacturing lines in France.{{Cite web |last=Whooley |first=Sean |date=2021-12-09 |title=Fareva, ApiJect ink 10-year licensing agreement on fill-finish production lines |url=https://www.medicaldesignandoutsourcing.com/fareva-apiject-ink-10-year-licensing-agreement-on-fill-finish-production-lines/ |access-date=2022-08-05 |website=Medical Design and Outsourcing |language=en-US}}

In April 2022, ApiJect opened the ApiJect Technology Development Center in Florida, with research and development investment from the U.S. Office of the Assistant Secretary for Preparedness and Response and the U.S. Department of Defense. The center works with pharmaceutical companies to develop prefilled injectors.{{Cite web |author=Staff Reports |date=2022-04-13 |title=ApiJect Systems opens technology development center in Orlando |url=https://floridapolitics.com/archives/516594-apiject-systems-opens-technology-development-center-in-orlando/ |access-date=2022-08-05 |website=Florida Politics |language=en-US}}{{Cite web |last=Galford |first=Chris |date=2022-04-25 |title=ASPR celebrates construction of new research and development facility for production of prefilled injectors |url=https://homelandprepnews.com/stories/76769-aspr-celebrates-construction-of-new-research-and-development-facility-for-production-of-prefilled-injectors/ |access-date=2022-08-05 |website=Homeland Preparedness News}}

In May 2022, ApiJect raised $111 million from Royalty Pharma and Jefferies Financial Group, valuing ApiJect at approximately $300 million.{{Cite web |last=Keenan |first=Joseph |date=2022-05-19 |title=Syringe maker ApiJect reels in $111M in private investment round |url=https://www.fiercepharma.com/manufacturing/apiject-reels-111m-private-investment-round |access-date=2022-08-05 |website=Fierce Pharma |language=en}}{{Cite web |last=Whooley |first=Sean |date=2022-05-18 |title=ApiJect picks up $111M investment from Royalty Pharma, Jefferies |url=https://www.drugdeliverybusiness.com/apiject-picks-up-111m-investment-from-royalty-pharma-jefferies/ |access-date=2022-08-05 |website=Drug Delivery Business |language=en-US}}

ApiJect’s prefilled injector uses Blow-Fill-Seal (BFS) manufacturing technology, which is recognized as an advanced aseptic liquid packaging process.{{Cite web|title=ApiJect selects IPS for Greenfield blow-fill-seal aseptic manufacturing campus|url=https://cleanroomtechnology.com/news/article_page/ApiJect_selects_IPS_for_Greenfield_blow-fill-seal_aseptic_manufacturing_campus/175751|access-date=2021-06-29|website=cleanroomtechnology.com}}  The prefilled injector is created by screwing the pen needle-style hub onto the top of the BFS container. BFS 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.

{{reflist}}

• {{official website|apiject.com}}
• [https://apiject.com/blow-fill-seal/ Blow-Fill-Seal Technology]

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Category:American companies established in 2018

Category:Companies based in Stamford, Connecticut

Category:Manufacturing companies based in Connecticut

Category:Medical technology companies of the United States

Category:Medical device manufacturers