ApiJect Systems

ApiJect Systems Corporation is an American company founded in 2018 by Marc Koska[2] and based in Stamford, Connecticut[3] that produces pre-filled single use plastic injectors.[4] ApiJect works with pharmaceutical and biotech companies to fill their injectable drug products into single-dose prefilled injectors.[5][6] The company claimed to have the capacity to manufacture pre-filled COVID-19 vaccine syringes[7][8] by the end of 2020.[9]

ApiJect Systems
IndustryMedical Technology
Founded2018 (2018)
FounderMarc Koska
HeadquartersStamford, Connecticut
Key people
[1]
ProductsPre-filled Injectors
Websiteapiject.com

History

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.[4][10] Koska previously invented the self-locking K1 syringe to prevent needle reuse.[11]

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.[12][10]

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.[13] 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.[14] The factory is designed to deliver production capacity of up to 2 to 3 billion units annually.[15] It will be suitable for vaccines requiring standard cold storage, including those in need of ultra-cold storage down to -70 degrees Celsius.[13]

As of April 21, 2021 the company has failed to produce any syringes,[16] 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.[17] 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.”[18] 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.[19]

In December 2021, ApiJect and Fareva announced a licensing agreement to establish three Blow-Fill-Seal manufacturing lines in France.[20]

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.[21][22]

In May 2022, ApiJect raised $111 million from Royalty Pharmaceuticals and Jefferies Financial Group, valuing ApiJect at approximately $300 million.[23][24]

Product

ApiJect’s prefilled injector uses Blow-Fill-Seal (BFS) manufacturing technology,[15] which is recognized as an advanced aseptic liquid packaging process.[25]  The prefilled injector is created by screwing the pen needle-style hub onto the top of the BFS container.[25] 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.[13]

References
  1. "ApiJect picks up $111M investment from Royalty Pharma, Jefferies" (website). drugdeliverybusiness.com.
  2. "ApiJect Systems Corp - Company Profile and News". Bloomberg.com. Retrieved 2021-04-21.
  3. "ApiJect Systems, Corp., Announces Appointment of Global Branding Leader, Craig Cohon as Chief Strategy Officer". www.prnewswire.com. Retrieved 2021-04-21.
  4. "Stamford company may play critical role in COVID vaccine delivery". fox61.com. Retrieved 2021-06-29.
  5. "Special Feature – PFS & Parenteral Drug Delivery: Self-Injection is Very Much the "New Normal"". Drug Development and Delivery. 2022-05-02. Retrieved 2022-06-27.
  6. "ASPR celebrates construction of new research and development facility for production of prefilled injectors". Homeland Preparedness News. 2022-04-25. Retrieved 2022-06-27.
  7. How Soft Plastic Vials Can Help Fight the Coronavirus Outbreak, retrieved 2021-04-22
  8. ApiJect CEO Expects Therapy to Blunt Coronavirus Death Rate by Summer, retrieved 2021-04-22
  9. "Trump admin to ramp up syringe production for future COVID-19 vaccine". NBC News. Retrieved 2021-04-21.
  10. "U.S. Bets On Small, Untested Company to Deliver COVID Vaccine". Frontline. Retrieved 2021-09-01.
  11. "4 innovations that found their use case during the pandemic - News". MM+M - Medical Marketing and Media. 2021-03-09. Retrieved 2021-06-29.
  12. "Trump admin to ramp up syringe production for future COVID-19 vaccine". NBC News. Retrieved 2021-06-29.
  13. "ApiJect snares $590M government loan for 'Gigafactory' to produce billions of prefilled vaccine injectors per year". FiercePharma. Retrieved 2021-06-29.
  14. Buckshon, Mark. "$785 million ApiJect Gigafactory in Durham among largest projects in nation to start, despite overall national decline: Dodge". Retrieved 2021-06-29.
  15. "Special Feature – PFS & Parenteral Manufacturing: How COVID-19 Changed the Market". Drug Development and Delivery. 2021-05-03. Retrieved 2021-06-29.
  16. "The U.S. awarded a firm $1.3 billion to make syringes. Where are they?". NBC News. Retrieved 2021-04-21.
  17. "The U.S. awarded a firm up to $1.3 billion to make syringes. Where are they?". NBC News. Retrieved 2021-06-29.
  18. "U.S. Bets On Small, Untested Company to Deliver COVID Vaccine". Frontlin. Retrieved 2021-04-21.
  19. "Building Resilient Supply Chains, Revitalizing American Manufacturing, and Fostering Broad-Based Growth" (PDF). WhiteHouse.gov. Archived (PDF) from the original on 2021-06-08.
  20. Whooley, Sean (2021-12-09). "Fareva, ApiJect ink 10-year licensing agreement on fill-finish production lines". Medical Design and Outsourcing. Retrieved 2022-08-05.
  21. Staff Reports (2022-04-13). "ApiJect Systems opens technology development center in Orlando". Florida Politics - Campaigns & Elections. Lobbying & Government. Retrieved 2022-08-05.
  22. Galford, Chris (2022-04-25). "ASPR celebrates construction of new research and development facility for production of prefilled injectors". Homeland Preparedness News. Retrieved 2022-08-05.
  23. Keenan, Joseph (2022-05-19). "Syringe maker ApiJect reels in $111M in private investment round". Fierce Pharma. Retrieved 2022-08-05.
  24. Whooley, Sean (2022-05-18). "ApiJect picks up $111M investment from Royalty Pharma, Jefferies". Drug Delivery Business. Retrieved 2022-08-05.
  25. "ApiJect selects IPS for Greenfield blow-fill-seal aseptic manufacturing campus". cleanroomtechnology.com. Retrieved 2021-06-29.
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