ApiJect selects IPS for Greenfield blow-fill-seal aseptic manufacturing campus

IPS has been chosen as a Key Partner to provide engineering, procurement, construction management, and validation (EPCMV) services for the Biosafety Level 2 Gigafactory

IPS-Integrated Project Services, a provider of engineering, procurement, construction management, and validation (EPCMV) services, has announced Key Partner Status with ApiJect Systems.

ApiJect, a medical technology public benefit corporation working to change how the world fill-finishes and delivers medicines and vaccines, selected IPS to deliver the ApiJect campus, a greenfield cGMP manufacturing campus project in Research Triangle Park, North Carolina.

The ApiJect campus represents ApiJect's future of manufacturing, capable of producing up to an estimated 3 billion Blow-Fill-Seal (BFS) prefilled injectors and other devices per year. With more than 1.2 million sqft of manufacturing space, the ApiJect campus and its central building, the "Gigafactory," will be able to fill-finish up to 15 different products simultaneously on 15 isolated production lines.

The first of 15 BFS manufacturing lines to fill-finish vaccines and other therapeutics are scheduled to be operational by late 2022

Needle hubs and connectors will also be manufactured on-site. The needle hub manufacturing facility on the campus will be co-owned and operated by Tae-Chang Industrial of South Korea.

IPS is providing a full array of engineering, design, and process architecture services for ApiJect's future Gigafactory and four additional campus buildings. The envisioned facility includes formulation, filling, inspection, and supporting functions for flexible and scalable sterile manufacturing; new warehouse including storage and staging areas; chemical, micro, and R&D laboratories; engineering and facility support systems; a facility devoted to the reshoring of needle hub manufacturing; and administrative offices and social spaces.

The Gigafactory will be Biosafety Level 2 (BSL-2) capable and support vaccine candidates that require standard cold or ultracold storage down to minus 70 degrees Celsius.

The first of 15 BFS manufacturing lines to fill-finish vaccines and other therapeutics are currently scheduled to be operational by late 2022. Each manufacturing line will be isolated, allowing for up to 15 different drugs to be packaged simultaneously.

"To be considered a key partner to a company that is revolutionising how the world gets injectable vaccines and medicines is quite an extraordinary and humbling experience," said Dave Goswami, IPS Chairman and CEO. "IPS prides itself on relentless innovation in project delivery to help get our clients' products to market faster. We are committed to supporting the mission of ApiJect and its pharmaceutical partners in the filling and finishing of vaccine and injectable medicines."

The technology

The ApiJect Prefilled Injector is the combination of two globally trusted pharmaceutical technologies: BFS and pen needles. Rotary BFS is recognised by the FDA as an advanced aseptic liquid packaging process. BFS manufacturing is trusted to package tens of billions of vaccines, therapeutics, and other sterile liquid pharmaceuticals every year.

Pen needles are used to deliver billions of insulin injections annually. All the healthcare professional has to do is screw the pen needle-style hub and connector onto the top of the BFS container to create the Prefilled Injector. This union brings together the convenience and quality of prefilled syringes with the low manufacturing cost and scalability of Blow-Fill-Seal.

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