A breakthrough in medical injections

ApiJect has completely reimagined how to make and fill a new kind of prefilled injector that can deliver medicines and vaccines with enormous speed, scale, and efficiency.

ApiJect Announces U.S. Government Support to Build New Pharmaceutical Packaging Facility

ApiJect approved for $590 Million loan from the U.S. International Development Finance Corporation to support building a U.S.-based pharmaceutical packaging facility.

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ApiJect^™ combines the globally trusted technology of Blow-Fill-Seal (BFS) aseptic plastic drug packaging with pen needle-style hubs*.

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BFS soft plastic containers package billions of doses a year.
Snapped together, these 3 components form the ApiJect Prefilled Injector.
A sterile Needle Hub and blue connector are snapped onto the container by the nurse.

*This device is not cleared by the FDA for distribution in the United States.

The ApiJect Prefilled Injector provides

Reliable aseptic filling

Single-dose safety

Ready-to-use

That’s why the U.S. Government is working with ApiJect to fill and finish COVID-19 vaccine and therapeutics as part of U.S. pandemic response.

We’re proud to partner with the U.S. Department of Health and Human Services and the U.S. Department of Defense to strengthen America’s medical supply chain on U.S. soil.

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ApiJect Prefilled Injectors are Ideal for Pandemic Response

In a national bio-emergency such as a pandemic, governments need to be able to package enough medicines or vaccines for their population on short notice. This "surge capacity" can be extremely difficult for traditional drug packaging supply chains to achieve.

ApiJect Prefilled Injectors are ideal for this challenge. A single BFS manufacturing line can reliably fill 15 million doses a month in ready-to-use single-dose presentations. That is why ApiJect is working with the U.S. Government on COVID-19 response.

Entering and Expanding Markets for Most Injectable Drugs

For decades, BFS has been used as primary packaging for a wide range of large and small molecules, as well as vaccines. ApiJect Prefilled Injectors unlock the reliable quality, scale, and manufacturing cost advantages of BFS for the injectables market.

Our products can open new markets for branded and generic injectable pharmaceuticals, as well as grow market share for more mature sectors. And, BFS efficiency gives pharmaceutical companies easy flexibility in scaling their operations.

Finally, a Single-Dose Format that Can Compete

For injectables in low- and middle-income countries, multi-dose vials are widely preferred for their low manufacturing cost. But multi-dose vials have significant safety and usage drawbacks. The BFS Prefilled Syringe changes this equation. With a projected total cost per delivered dose that can compete with multi-dose vials and syringes, our injector enables pharmaceutical companies to give consumers everywhere the safety and convenience of a single-dose, ready-to-use presentation.

The Potential to Unlock Access for Everyone

A single Rommelag® bp460 BFS machine can aseptically package 15 million doses a month. When combined with ApiJect’s Needle Hubs, these BFS containers become prefilled injectors, ready to use with vaccine, and scalable in very large quantities.    What’s more, as a single-dose presentation, the injector improves patient safety and healthcare convenience without increasing the total cost per delivered dose above that of WHO-approved multi-dose formats. Put together, it’s easy to see why ApiJect believes BFS prefilled, single-dose injectors are the key to improving access everywhere.

Blow-Fill-Seal is a trusted technology for aseptically fill-finishing drugs.

BFS is a globally-trusted, 50+ year-old packaging technology that fills and finishes tens of billions of inhalation, ophthalmics and injectable products including biologics, oral vaccines, and other drugs. In 2004, FDA guidance deemed BFS a proven advanced aseptic packaging process.

Biologics and vaccines that have been successfully filled (and several commercialized) in BFS primary packaging include RSV, Influenza, and rotavirus vaccines.

A non-stop 3-second process

BFS is a highly efficient, low-human-intervention drug packaging process. Every three seconds, a high-end BFS machine can reliably make and aseptically fill up to 25 medical-grade polymer containers (that’s up to 200 million units a year).

01 Extruding

BFS machine pours molten plastic into tube shape (“parison”) inside an ISO 5 clean space.

02 Blowing

Airstream blows parison open. Bottom mold closes to create 2-cavity shape.

03 Filling

Rod inserted to fill parison with precise dose of liquid vaccine or medicine.

04 Sealing

Upper mold closes, sealing the top of container.

A Global Network for Manufacturing BFS Prefilled Injectors

ApiJect believes any organization should be able put its drug products in BFS prefilled, single-dose injectors. That is why ApiJect, in addition to establishing its own BFS facilities, is working with pharmaceutical companies and contract manufacturers to set up BFS manufacturing lines within their own facilities.

ApiJect’s first company-owned facility in North Carolina, USA will be able to fill and finish 2-3 billion injectors every year for our pharma partners, with nearly every line BSL-2 compliant and segregated for independent fill and finish.

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The latest ApiJect news

11.24.2020

The ApiJect Gigafactory, featuring the world’s largest pharmaceutical fill-finish facility

ApiJect Systems, Corp., a medical technology company that seeks to change how the pharmaceutical industry fills, finishes, and delivers medicines and vaccines, announced that the U.S. government has given a loan to help build the “Gigafactory” in Research Triangle Park, NC.

11.21.2020

In COVID-19 fight, ApiJect is ready to produce 45 million prefilled syringes a month

In South Carolina, prefilled syringe maker ApiJect is prepared to start turning out 45 million prefilled syringes a month in the fight against COVID-19.

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