The Future of Liquid Pharmaceutical Packaging
Opening in 2022, the new ApiJect Campus and its Gigafactory will provide a world-class solution for partners desiring fill and finish injectable drug products.
Located in North Carolina, the ApiJect Campus will enable any organization to package its injectable medicines and vaccines in ApiJect’s prefilled devices, helping pharmaceutical partners enter new markets and reach more patients. And at its center is ApiJect’s Gigafactory, the world’s largest pharmaceutical fill and finish facility.
Once completed, the ApiJect Campus will be able to fill and finish up to 3 billion single-dose containers of sterile liquids a year.
At the core of ApiJect’s injection devices and our manufacturing is Blow-Fill-Seal (BFS), a globally trusted packaging process. BFS is recognized by the FDA as an advanced aseptic filling process. Learn more about BFS here.
Each of the Gigafactory’s segregated 15 BFS production lines can aseptically package upwards of 8 to 15 million doses a month – in single-dose pharmaceutical-grade polymer containers – reliably and with almost no human intervention.
BSL-2 and Cold Chain on Every Line
All 15 BFS lines in the Gigafactory meet Bio Safety Level 2 (BSL-2) cleanroom standards for vaccine packaging. Each line is isolated, supporting the simultaneous manufacture of more than a dozen different drugs.
In addition, each line is equipped with temporary cold-chain storage to handle product during manufacturing. Separately, more extensive cold-chain capacity is available in-house for post-manufacturing storage over a longer term, suitable for the vast majority of drug products.
Custom Device Design
At ApiJect, we understand that every drug product in every market has different needs and specifications. That is why our team of world-class BFS engineers and device designers work with pharmaceutical partners to design prefilled injectors to meet their drug product’s needs.
These services include BFS mold design, secondary packaging and product assembly, regulatory support, and more. At the end, we customize our devices to ensure they best serve our partner’s needs.
To learn more about our first device, the ApiJect Prefilled Injector, click here.
ApiJect Campus Stats at a Glance
Research Triangle Park, North Carolina, USA
Number of buildings on campus
Number of isolated BFS lines
BFS line features
Aseptic filling, BSL-2 equipped, Temporary cold chain
Cold and freeze chain storage, Large onsite materials stockpile
Annual production capacity
3 billion finished units
Number of secondary packaging lines
A Compact, Simplified Supply Chain
The supply chain for ApiJect’s medical devices is much simpler and shorter than those required for traditional pharmaceutical fill and finish. With a simplified supply chain, continuous operations become far more reliable, even when traditional supply chains are disrupted by a pandemic or other national emergency.
For example, the Prefilled Injector requires only two raw materials: pharmaceutical-grade polymer (plastic) and stainless-steel ribbons. Both can normally be sourced domestically and will be stored in large quantities on the ApiJect Campus.
To learn more about ApiJect’s devices and technology platform, click here.
Needle Hubs Manufactured Onsite
The ApiJect Campus will have its own Needle Hub Manufacturing Facility onsite. Jointly operated by ApiJect and one of the world’s largest needle and cannula manufacturers, this facility will be able to produce enough Needle Hubs for every BFS container produced at the Gigafactory, and beyond.
Onsite needle manufacturing further strengthens the ApiJect’s Campus’ reliability to package and deliver finished products on time, enabling it to continue operations even during emergencies that disrupt global supply chains.
Opening in 2022
Construction of the ApiJect Campus is now underway, with the first BFS production line scheduled to be operational in the first half of 2022. Additional manufacturing lines are slated to come online in the following months.
To learn more about the ApiJect Campus and how it can serve your company, contact us at email@example.com.
Learn more about Blow-Fill-Seal
Discover why Blow-Fill-Seal is at the center of ApiJect’s technology platform and the manufacturing capacity.
ApiJect Prefilled Injector