AnteoTech will procure a test strip manufacturing line developed for the EuGeni platform for its Brisbane facility, as part of a decentralised and diversified global manufacturing approach.
The strategy considers two elements for the production of the EuGeni platform:
- Lateral flow strip manufacture, which includes the preparation and incorporation of the required macromolecules (e.g. antibodies or antigens) and AnteoBind activated Europium particles ready for assembly.
- Cassette assembly and kit packaging including pre-filling of all liquid into ready-to-use buffer bottles.
AnteoTech plans to commence in-house manufacturing to enable the production capability of an additional 12 million test strips per year, with only in-house technology transfer required. This will ensure new tests will be brought to market quickly and most cost effectively. It will also provide additional manufacturing to meet the demand for the EuGeni tests.
Objectives which have been taken into consideration for the manufacturing strategy include:
- Circumventing the long lead time for AnteoTech to undertake technical transfer to a third party for scale-up of lateral flow strip manufacture. E.g. the time to complete the technical transfer to Operon for the COVID-19 ART was 8 months.
- Improving efficiency of cassette assembly and packaging which is a time-, capital- and labour-intensive process that has a number of rate-limiting steps including pre-filling of buffer bottles. The process requires ISO 13485 based technical transfer but is less complex and takes less time than the technology transfer for the lateral flow strip production.
- Mitigating contract supply risk so lateral flow strips can be produced in-house efficiently and in high volume on a reel-to-reel machine. These rolls can then be cut into cards and easily transported globally.
The key benefits of AnteoTech’s manufacturing strategy are increased speed to market, by focusing initially on lateral flow strip manufacture for one or two sites; and decreased production costs, via implementing multiple cassette assembly and packaging facilities close to the markets they serve.
Overall, this will decrease the time required for technical transfer to a third party for new tests and will leverage mass production capability at each site. It also means reduced reliance on one assembly partner, decreasing the logistics risks associated with transporting kits globally from a single location and reduced contract supply and global supply chain risks.
AnteoTech is progressing discussions with Axxin to increase production of the EuGeni reader and reviewing other reader options, to enable rapid testing for different market segments.
“Our manufacturing strategy will enable AnteoTech to produce tests inexpensively and efficiently,” AnteoTech CEO Derek Thomson said.
“Implementation of lateral flow test strip manufacture inhouse will enable us to produce new products and get them into the market without lengthy technical transfer processes to third parties. This will increase our speed to market and ensure quality.
Our current lateral flow test strip capacity from Operon is 20M lateral flow strips per year. Our initial investment in Brisbane will increase that capacity by an estimated 12M lateral flow strips per year. We will increase this capability as required as EuGeni test demand across the entire range of tests we produce grows.
“We are also excited about the prospect of leveraging new cassette assembly and packaging capability around the globe. We are moving swiftly to harness this opportunity to align with the expected increase in demand for EuGeni tests in the future.”