A new facility brings critical capabilities to the United States for the design, engineering and testing of ApiJect’s high-volume manufacturing process for manufacturing single-dose prefilled syringes.
STAMFORD, Conn., April 13, 2022 /PRNewswire/ — ApiJect Systems, Corp., a public utility medical technology company that will transform the way vaccines and injectable drugs are filled, finished and delivered, today announced the launch of the Technology Development Center ApiJect in a larger Orlando, Florida.
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, for short) 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 the same roof. The ApiJect center also allows the filling-finishing of smaller batches for feasibility tests and device usability tests, leading to commercial development.
CEO of ApiJect Jay Walker commented, “The ApiJect Center is where the future of injection technology will be created. The center adds critical development capability that supports ApiJect’s existing fill-finish lines at the our manufacturing partner at Caroline from the south, which currently has the capacity to produce up to 540 million single-dose prefilled injectors 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 critical need for refill capacity. and finishing 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 16,000 square feet is just the beginning. Over the next year, the ApiJect Center will double in size The current BFS machines will be supplemented by two additional machines The ApiJect Center, here at Central Floridawill be a launching pad for the future of injectable device technology.”
“Strengthening our country’s healthcare supply chain and expanding domestic manufacturing capacity are key priorities for ASPR,” the assistant secretary for preparedness and response said. Dawn O’Connell. “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 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.
Bob WardPresident and CEO, Florida Council of 100, a nonprofit organization of presidents and CEOs, said, “We are thrilled to welcome ApiJect as another great example of a medical technology company growing Florida’s healthcare innovation sector. ApiJect is exactly the kind of company that is building a strong economic future for our state and its citizens.”
ApiJect completed the initial design and construction phase of the ApiJect Center in 9 months and within budget. Once fully constructed, the ApiJect Center will contain infrastructure for device prototyping and development via US FDA Current Good Manufacturing Practices (cGMP), fill, finish and scale production commercial.
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).
- Innovations in temperature management to expand the range of drugs and vaccines suitable for BFS packaging.
The ApiJect Center team includes BFS experts, device engineers, machinists and scientists, each with years of experience in the field. The team will provide ApiJect with the ability to deliver process and product proof of concept and small-scale manufacturing supporting business development. For a more complete description of the Best-in-Class services and the technology that supports them, please click on the following link: https://apiject.com/wp-content/uploads/2022/04/70820_Data-Sheet -only_3.pdf.
About ApiJect Systems
ApiJect Systems, Corp. is a public benefit medical technology company working to use our platform to bring more single-dose prefilled injections to patients around the world. The ApiJect platform enables pharmaceutical and biotechnology companies to design scalable prefilled injectors and efficiently fill and finish them with their injectable drug products. This can be done either on one of their own ApiJect licensed Blow-Fill-Seal packaging lines or at one of our world-class manufacturing partners.
SOURCEApiJect Systems Corp.