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Apiject Simplifying Drug Delivery with its Prefilled Injection Devices

Apiject Simplifying Drug Delivery with its Prefilled Injection Devices

Molly Weaver and Paul Rutter , Chief Operating Officer and Senior Vice President-Clinical Affairs, Apiject

2025-01-02

Q: What differentiates Apiject’s solutions from its competitors in the market and how does Apiject ensure that its devices remain affordable while maintaining high quality for LMIC markets?

Molly Weaver: Apiject combines blow-fill-seal (BFS) with an attachable needle hub, transforming BFS containers into prefilled injection devices. The BFS process uses less energy, less water, and less plastic than traditional glass vials and syringes, making it an environmentally friendly and sustainable technology. The scalability of BFS allows Apiject to open new markets, especially in regions where cost and accessibility are critical.

Paul Rutter: Providing an affordable, high-quality pre-filled device for LMIC markets is the reason Apiject was founded. Our technology provides the benefits of a prefilled device at a lower cost than traditional pre-filled syringes. This is possible because of the inherent low-cost and high-reliability of the Blow-Fill-Seal process. This process is widely used in the pharmaceutical industry – particularly for ophthalmic and inhaled products.

Q: Can you explain how ApiJect manages regulatory challenges for injectable devices across diverse global markets?

Molly Weaver: Each market has its own regulatory framework but there are initiatives which harmonize regulatory requirements across regions to streamline the approval process and reduce discrepancies.  It is important to be proactive with early engagement and communication with regulatory bodies during the development process. Apiject partners with drug sponsors to identify target markets and establish the most effective way to navigate the regulatory market.

Q: How does Apiject test the device’s efficacy and safety for contraceptive delivery specifically?

Paul Rutter: Apiject is developing a specific device for contraceptive delivery. For contraceptives and many other drug products, Apiject is partnering with pharmaceutical companies, who remain the marketing authorization holders. Apiject is active in those partnerships. Our team has extensive experience of the development and studies required to ensure efficacy and safety, and to gain regulatory approval.

Q: What protocols does ApiJect follow to test the injectors for different drug formulations and how does ApiJect’s technology address the common storage and distribution challenges in LMICs?

Molly Weaver: Apiject's first product is a prefilled injection device and we have identified a set of performance criteria against which our device is evaluated. We utilize a risk-based approach to product development and, together with the drug partner, utilize a set of validated test methods to ensure the product is safe and effective for the target user in the target market.

Paul Rutter: Apiject understands the challenges of last-mile delivery in LMICs extremely well. Our team has decades of experience studying and addressing these, and we have conducted extensive field research in India and elsewhere. We understand that plastic is substantially better than glass for transportation, avoiding breakages in even the harshest conditions. We are optimizing our designs to reduce the storage space required.

Q: Could you discuss any software tools or simulations ApiJect uses to model injection device performance?

Molly Weaver: Apiject uses a wide range of tools to support development and commercialization of our technology including analytical models of injection performance, mold flow simulation, prototyping, testing, finite element analysis (FEA), and in-country user studies leveraging our global field network.

Q: What long-term goals does Apiject have for expanding access to injectable medications in LMICs?

Paul Rutter: Apiject’s founding mission is to expand access to injectable medicines and vaccines. This technology can substantially help to do so. First, the easy-to-use prefilled format enables delivery by a wider range of healthcare professionals, and by patients themselves. This is important in the case of contraceptives, for example, which could be injected by Community Health Workers or by women themselves. Second, Apiject makes distributed manufacturing or fill-finish feasible and attractive. So, we enable both the production and delivery of injectable products as close as possible to where the patient lives.

Articles about interviews | January - 02 - 2025

 

 

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