This new facility is dedicated to working with pharmaceutical companies to design, engineer and test how to fill and finish their injectable drug products in a new type of scalable single-dose prefilled injector manufactured using the ApiJect platform. . By combining the high-speed, high-volume Blow-Fill-Seal (BFS) manufacturing process with removable components, including needle hubs, the ApiJect platform is designed to enable more drugs and vaccines injectables to be filled and delivered efficiently. to patients in a pre-filled injection device. This facility provides capabilities to shorten supply chains and bring critical injection device technology development back to the United States
With public-private partnership support from the U.S. Department of Health and Human Services – Office of the Assistant Secretary for Preparedness and Response (ASPR) and the U.S. Department of Defense, the ApiJect Technology Development Center (the ApiJect) brings to the United States critical capabilities for device design, engineering, testing, BFS mold development, and small-scale manufacturing of single-dose prefilled injectors and other parenteral devices under one same roof. The ApiJect center also allows the filling-finishing of smaller batches for feasibility tests and device usability tests, leading to commercial development.
“The ApiJect Center is where the future of injection technology will be created,” said Jay Walker, CEO of ApiJect. “The center adds critical development capability that supports ApiJect’s existing fill-finish lines at our manufacturing partner site in South Carolina, which currently has the capacity to produce up to 540 million prefilled injectors. dose per year.Together, these facilities expand the national pharmaceutical supply chain and catalyze our ability here in the United States to address key public health issues such as syringe shortages, syringe safety, and the need critical of state-of-the-art fill-finish capability not only for this global pandemic, but also for future pandemics and bio-emergencies.
Mr Walker continued: “There has been a lot of talk over the past few years, rightly so in my view, about the need to shorten supply chains and have critical technologies here in the United States. Our partners in the government have strongly emphasized this priority since the pandemic. The ApiJect Center was created for this purpose. Its current footprint of 1,600 square meters is just the beginning. Over the next year, the size of the ApiJect Center The current BFS machines will be supplemented by an additional two machines. The ApiJect Center here in Central Florida will be the launch pad for the future of injectable device technology.”
Assistant Secretary for Preparedness and Response Dawn O’Connell said, “Strengthening our nation’s health supply chain and expanding domestic manufacturing capacity are key priorities for ASPR. . We are pleased to support ApiJect’s efforts to develop new and innovative approaches to how vaccines and injectable medications are filled, finished and delivered so that the nation is prepared for future pandemics and health emergencies. »
The ApiJect Technology Development Center is made possible in part by $9.6 million in funding from the HHS Office of the Assistant Secretary for Preparedness and Response. The ASPR leads the federal government’s health care and public health preparedness, response and recovery efforts.
ApiJect completed the initial design and construction phase of the ApiJect Center in 9 months and on budget. Once fully constructed, the ApiJect Center will contain infrastructure for device prototyping and development through fill-finish and commercial-scale production compliant with current US FDA Good Manufacturing Practices (cGMP).
The first potential device manufactured on the ApiJect platform is the ApiJect Prefilled Injector, a single-dose prefilled injector designed to efficiently deliver a 0.5ml dose to a patient with a single press of the BFS container by the healthcare professional. health. This new type of prefilled syringe will be ApiJect’s first product to undergo regulatory review and approval. The ApiJect pre-filled injector and its manufacturing process include:
• An aseptically filled single-dose container designed to allow efficient and intuitive administration of injections;
• Pen needle style hub (including patented connector for BFS container interface and needle hub mounting); and
• Innovations in temperature management to expand the range of drugs and vaccines suitable for BFS packaging.
Visit Apiject at CPhI booth NA 608