Solving drug delivery challenges

ApiJect is helping pharmaceutical companies fill, finish, and deliver injectable medicines to more patients and markets with scalable, prefilled drug delivery systems.

ApiJect's Ed Kelley and Global Health Leaders Highlight Injection Safety in Washington Post Op-Ed

Our colleague Ed Kelley, PhD, and several other leading global health experts, highlight the importance of injection safety and ensuring there are enough syringes as COVID-19 rollout continues across the world.

READ WASHINGTON POST OP-ED

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

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BFS plastic containers package billions of doses of pharmaceuticals a year.
Snapped together, these 3 components form the ApiJect Prefilled Injector.
A sterile Needle Hub and blue Connector are attached to the container by the nurse.

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

The ApiJect Prefilled Injector is designed to provide

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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Prefilled Simplicity can Assist in 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 can assist with meeting 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.

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 combine the reliable quality, scale, and manufacturing cost advantages of BFS with the convenience of prefilled syringes 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.

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 prefilled injector has the potential to improve patient safety and healthcare convenience without increasing the total cost per delivered dose above that of WHO-approved multi-dose formats.

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. BFS is considered by industry and regulators as an advanced aseptic packaging process.

Publicly known 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 15 million units a month).

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 Compact, Resilient Supply Chain

The drug delivery systems made on ApiJect’s Technology Platform use an alternative supply chain to the one used by standard glass vials and syringes.

ApiJect’s supply chain is much more compact, requiring as few as two facilities and only two primary materials to create a Prefilled Injector: pharmaceutical-grade polymer and hypodermic needles.

The compact, simplified nature of ApiJect’s supply chain also makes it resilient, as both primary materials can typically be sourced from multiple suppliers within most major pharmaceutical markets. And ApiJect is working with leading contract manufacturers to provide additional capacity to serve pharmaceutical partners that prefer outside manufacturing services.

Learn More About the BFS Supply Chain

The latest ApiJect news

10.12.2021

ApiJect Chief Global Health Officer Ed Kelley to Participate in INTERPHEX Live, Headlining Conversations on Fill-Finish Strategies and Global Supply Chain

INTERPHEX Live offers prerecorded interviews and discussion on the latest, cutting-edge pharmaceutical and biopharmaceutical technologies. INTERPHEX Live is part of the technical conference at INTERPHEX, taking place October 19-21, 2021, in New York, NY.

09.27.2021

How Lessons from Ebola can Help in the Fight Against COVID-19

ApiJect’s Ed Kelley and other leading researchers and global health experts look at some of the lessons drawn from the 2015 response to Ebola and how the focus on the “last mile” is crucial if the world is going to effectively respond to COVID-19.

READ HERE >

09.25.2021

Op-Ed: A lesson from Ebola in 2015 will be key to ending COVID-19, LA Times

We proudly support the work of Ed Kelley, PhD, ApiJect; David Heyman, London School of Hygiene and Tropical Medicine; and Ashish Jha, Brown University School of Public Health.

Get in touch to explore opportunities.

To learn more about how the ApiJect Prefilled Injector can serve your company’s drug products and open new opportunities, contact our team.