This new facility is devoted 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 that is made using the ApiJect Platform. By bringing together the high-speed, high-volume Blow-Fill-Seal (BFS) manufacturing process with attachable components, including Needle Hubs, the ApiJect Platform is designed to make it possible for more injectable medicines and vaccines to efficiently be filled and delivered to patients in a prefilled injection device. This facility provides capabilities to shorten supply chains and bring the development of critical injection device technologies back to the U.S.
With the public-private partnership support of 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 Center) brings to the U.S. 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 roof. The ApiJect Center also enables the fill-finish of smaller batch sizes for feasibility testing and device use testing, leading to commercial development.
“The ApiJect Center is where the future of injection technology will be created,” said Jay Walker, CEO, ApiJect. “The center adds a 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 single-dose prefilled injectors annually. Together, these facilities expand the domestic pharmaceutical supply chain and catalyze our ability here in the U.S. to respond to key public health issues such as syringe shortages, syringe safety, and the critical need for surge fill-finish capacity not only for this pandemic worldwide, but also for future pandemics and bio-emergencies.”
Mr. Walker continued, “There has been much discussion in recent years, rightly focused in my judgment, about the need to shorten supply chains and have critical technology here in the U.S. Our partners in the U.S. Government have strongly emphasized this priority from the pandemic’s very beginning. The ApiJect Center has been created to serve just such a purpose. Its current footprint of 16,000 square feet is just a start. Over the next year, the ApiJect Center will double in size. The current BFS machines will be supplemented by an additional two machines. The ApiJect Center, here in Central Florida, will be launchpad 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 injectable vaccines and medicines 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 due to $9.6 million in funding from the HHS Office of the Assistant Secretary for Preparedness and Response. ASPR leads the federal government’s health care and public health preparedness, response, and recovery efforts.
ApiJect completed the ApiJect Center’s initial phase of design and construction within 9 months and on budget. When fully built out, The ApiJect Center will contain infrastructure for device prototyping and development through U.S. FDA Current Good Manufacturing Practice (cGMP) compliant commercial scale fill-finish and production.
The first potential device made on the ApiJect Platform is the Prefilled ApiJect Injector, a single-dose prefilled injector designed to efficiently deliver a 0.5mL dose into a patient with a simple squeeze of the BFS container by the health professional. This new type of prefilled syringe will be ApiJect’s first product submitted for regulatory review and approval. The Prefilled ApiJect Injector and its manufacturing process include:
• An aseptically filled single-dose container, designed to enable efficient and intuitive injection administration;
• Pen needle-style hub (including a patented connector for BFS container interface and Needle Hub mounting); and
• Innovations in temperature management to expand the range of medicines and vaccines suitable for BFS packaging.