Offering Design, Engineering and Testing of ApiJect’s High Volume Manufacturing Process for Manufacturing Single-Dose, Prefilled Syringes
About The Technology Development Center
Located in the greater Orlando, Florida-area, the ApiJect Technology Development Center is focused on helping pharmaceutical companies prepare their drug product for high-speed, high-volume production in a new type of scalable prefilled syringe* that is made largely using the Blow-Fill-Seal aseptic process. The Center directly supports the future installation of large-scale commercial manufacturing for rapid deployment of critical medications.
*The Prefilled ApiJect Injector and its components are not cleared by the FDA or other regulatory bodies.
- Manufacturing for Feasibility Testing
The Center can readily prepare the drug product for feasibility testing if a company chooses to undertake this step.
- BFS Mold Design
Our world-class experts work with the pharma partner to design custom molds that meet the drug product’s requirements.
- BFS Prototype Mold Production
Our experts will take the mold design and create BFS molds for prototype and development manufacturing.
- Rapid Prototype Testing
Working alongside the pharma conmpany, our team will produce prototype BFS-based combination devices, test their performance, and integrate feedback in a rapid iterative process towards an approved final design.
- Foil Packaging for Stability
The Center offers on-demand capability to wrap BFS containers in foil pouches that can be used in stability testing.
- Small Batch Manufacturing (future)
ApiJect is expanding the Center. Once completed, we will be able to run small batch cGMP manufacturing in BFS. This can include filling BFS containers for stability testing in preparation for regulatory submission.