ApiJect raises $111m to support new fill-finish system

24-May-2022

The funds have been raised for the continued development of ApiJect's proprietary Blow-Fill-Seal (BFS) plastic prefilled injection system among other things

ApiJect Holdings, the parent company of ApiJect Systems, Corp., a medical technology public-benefit corporation transforming the fill and finish and delivery of injectable vaccines and medicines, has completed a $111 million private round of investment.

The new round was led by Royalty Pharma and Jefferies Financial Group, which acquired a revenue interest in addition to equity.

The funds will be used for the continued development of ApiJect's proprietary Blow-Fill-Seal (BFS) plastic prefilled injection system, to deploy its equipment and proprietary technologies to licensees, and for general working capital purposes.

BFS is cost-efficient for short and long runs, and highly suitable to scale quickly in order to meet unexpected spikes in demand

ApiJect is developing an innovative portfolio of drug delivery devices using high-speed BFS manufacturing, which is recognised by the FDA as an advanced aseptic process that forms, fills and seals a single unit dose in a continuous, automated manufacturing step.

BFS technology greatly reduces the risk of contamination and error during one of the most critical steps of drug production. BFS is cost-efficient for short and long runs, and highly suitable to scale quickly in order to meet unexpected spikes in demand such as for a rapid response to population-scale health emergencies. Advancements developed by ApiJect for temperature management now enable BFS manufacturing of a vast array of sterile injectable drugs, including ultra-cold mRNA vaccines.

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ApiJect CEO Jay Walker said: "This is an important day for injection device innovation, and, with that, the future health of billions of people throughout the world. The investment provided by Royalty Pharma and Jefferies supports further development of an injection technology that can scale rapidly and efficiently to meet global demand for injectable medicines."

"We are delighted to form this win-win partnership with ApiJect," said Pablo Legorreta, Royalty Pharma's Founder and CEO. "The global pandemic highlighted the clear unmet need for a new kind of prefilled syringe that can be rapidly produced to respond to public health threats, and at massive scale that would be capable of delivering hundreds of millions, potentially billions, of doses to people in the US as well as globally."

Progress

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 healthcare professional. This new type of prefilled injector 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.
  • A pen-needle-style hub (including a patented connector for BFS container interface and Needle Hub mounting) that turns the BFS container into an injection device.
  • Innovations in temperature management to expand the range of medicines and vaccines suitable for BFS packaging.

ApiJect recently launched its Technology Development Center in the greater Orlando area to bring to the US critical capabilities for device design and engineering, and BFS mold development, as well as for small-scale manufacturing of single-dose, prefilled injectors and other injectable devices. Its purpose is to dramatically reduce the time and processes necessary for product development.

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ApiJect's Technology Development Center supports the company's existing fill-finish lines at its manufacturing partner site in South Carolina, which currently has the capacity to produce up to 540 million single-dose prefilled injectors annually.

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