The ApiJect Technology Platform is the framework ApiJect uses to design and manufacture its injectable devices.
ApiJect’s Platform brings together Blow-Fill-Seal (BFS) drug filling and finishing technology with open, modular manufacturing. We use this platform to design and produce drug delivery devices featuring simple, interlocking components. This platform allows any pharmaceutical company to package and sell their drugs in ApiJect-designed devices.
At the center of the ApiJect platform is Blow-Fill-Seal (BFS), an advanced aseptic drug filling and finishing process. The reliability and efficiency of BFS allow for any size order, large or small, to be fulfilled with reliable quality at high speeds and volumes.
Because BFS makes and fills containers of polymers, such as polypropylene (PE) and low-density polyethylene (LDPE), those containers can be formed into nearly any size volume and shape. ApiJect has produced a range of molds to cover various size injections and we can create custom container designs and sizes as needed.
Once a drug product is packaged in BFS containers, ApiJect provides the attachments and supporting services that administer the drug product. These components are manufactured and shipped by ApiJect to either the BFS manufacturing facility or the final destination of the finished drug product.
These components and services include:
To inject various size doses and viscosities.
To ensure the BFS container cannot be refilled.
Using RFID/NFC tags to ensure authenticity of the drug dose.
To deliver a variable dose in a simple, inline process.
To help any healthcare worker with arthritis to administer an injection.
To administer two separate drugs at once.
The ApiJect Technology Platform makes it easy for any organization to package its medicines and vaccines in BFS Containers that plug into ApiJect Prefilled Injectors.
A pharmaceutical company can either (a) have ApiJect do this in our facilities; (b) use a trusted CMO; (c) establish a proprietary BFS production line in its own facility.
ApiJect provides extensive advisory services and mold designs, making it an easy, straightforward and low-risk option for any pharma company to set up its own in-house BFS line to package its drugs in ApiJect Prefilled Injectors.
Blow-Fill-Seal (BFS) is a compact manufacturing process, typically taking up only 18,000 – 21,000 sq. ft. of cGMP floor space, including labeling and secondary packaging. And the supply chain to serve it only requires plastic resin, which is widely available.
In addition to helping our pharmaceutical partners set up their own manufacturing, ApiJect is building facilities to provide our BFS services in-house.
Our first facility in the U.S., the Gigafactory in North Carolina, will be able to handle 2-3 billion doses a year, outfitted with BSL-2 environments and freeze chain capabilities.
Learn MoreTo ensure reliable, high-quality products and solutions, ApiJect offers support services for every step of the process. These products and services include:
ApiJect works with pharmaceutical partners to create the manufacturing setup that works for them.
If the partner wants ApiJect to handle the fill and finish of their drug product, we are well equipped to handle that.
If the pharmaceutical partner chooses to fill their drug product outside of an ApiJect facility, such as in their own facilities or at a trusted 3rd party, ApiJect is there to provide turnkey guidance and design services to make this process as easy and successful as possible.
ApiJect’s BFS mold designers will work with the pharmaceutical company to select the right mold for each of their drugs. For example, when delivering a single dose, ApiJect has predesigned molds for a up to a 2.0mL delivered dose.
If custom changes are required, ApiJect has a world-class team of BFS designers to ensure a smooth and highly-efficient drug delivery.
Different drug products require different packaging solutions.
That is why ApiJect engineers work with our pharmaceutical partners to design the best packaging line for each drug product and the market it is serving – all within any constraints of the packaging facility. This includes maximizing cold-chain efficiency if the situation calls for it.
ApiJect will provide all of the necessary design history files and predicate test results for the BFS containers and other necessary components that the pharmaceutical partner will need to provide to regulators.
Further, ApiJect's team will work with the pharmaceutical partner on drug development in BFS, if requested by the partner.