The funding was provided to ApiJect Systems America, which specializes in producing plastic prefilled syringes. The syringes can be manufactured at a lower cost and higher speed than traditional glass vials, the organization claims.
The US Department of Health and Human Services (HHS) and the Department of Defense (DOD) awarded the company a contract worth up to $138m (€127m) to provide a US-based means of producing high numbers of prefilled syringes for a potential vaccine against the novel coronavirus.
ApiJect, through its subsidiary Rapid USA, will aim towards producing 100 million prefilled syringes by the end of 2020, as part of ‘Project Jumpstart’.
Following this, the plan is to raise this to more than 500 million in 2021, before a separate project to expand capacity further reaches a point where monthly production of 330 million syringes is possible.
Infrastructure requirements
In terms of the infrastructure required behind this effort, ApiJect stated that it will contract existing US-based blow-fill-seal (BFS) facilities to install filling lines and technical additions allowing for the production of prefilled syringes.
This step would see the manufacture of a minimum of 30 million prefilled syringes per month, once there is a therapeutic drug or vaccine available for COVID-19. This is part of the first stage of ApiJect’s partnership with HHS.
Alongside Project Jumpstart, ApiJect will also develop a network of 30 US-based BFS manufacturing lines at three sites across the US, which will provide the capability to fill, finish, and package 330 million prefilled BFS syringes per month.
The organization stated that it expects initial production to begin on these lines in late 2021, though work on completing all lines is expected to finish in 2022.
Prior to yesterday’s announcement, HHS had provided ApiJect with up to $456m to create year-round domestic manufacturing facilities for the prefilled syringes in March of this year.
The prefilled syringe
The syringe itself was invented to create a low-cost, single-use device that could be manufactured at high speed and in large volumes.
The original idea was to prevent the re-use of syringes, which led to the annual deaths of 1.3 million people in 1999. The founder of ApiJect, Marc Koska, created a plastic syringe that would lock on first use and then break should there be an attempt to reuse it.
The product was originally designed for use in less economically developed countries, where the issue of reuse was more prevalent.
However, the speed at which the prefilled syringes can be produced has now attracted the attention of the US government, as it develops its capability to rapidly roll out a potential vaccine.
Mike Andrews, Department of Defense spokesperson, added that it allows the country greater control of the supply: “Rapid’s permanent fill-finish production capability will help significantly decrease the US’ dependence on offshore supply chains and its reliance on older technologies with much longer production lead times.”
Demand set to soar on basic materials
This week, Pfizer noted that a potential shortage of basic materials was one of the reasons it was looking to outsource the production of certain brands.
In particular, the company suggested that it could face an internal shortage of vials and syringes, as it works to increase production capacity of its potential COVID-19 vaccine into the hundreds of millions.
This is likely to be an issue across the industry, with both Johnson & Johnson and Moderna setting themselves the aim of being able to produce one billion doses of commercial vaccine by next year, in the event of a product approval.
