In early 2018, Abingdon Health was awarded an Innovate UK grant to develop a multiplexed on-farm rapid test to identify mastitis in cattle. Mastitis (udder inflammation) affects milk production in cattle and is currently detected by visual inspection of milk, temperature monitoring or via laboratory methods, all of which have limitations and are time-consuming.
The following highlights the path the test will follow through development and manufacture. This process is representative of the process undertaken via our lateral flow assay and reader contract services:
- Grant funding
- Assay development
- Regulatory approval
The project will combine the lateral flow assay development expertise at Abingdon Health with the animal health and biomarker knowledge at the University of Glasgow in order to develop an on-farm tool to tackle the global problem of mastitis in cattle.
Abingdon Health has formed relationships with a variety of organisations over the years. Another example of this is our collaboration with the University of Birmingham on Seralite®- FLC.
The commencement of the project has been possible because of grant-funding via Innovate UK. Grant funding was awarded due to internal project expertise and market knowledge, and our intended approach to assay development, manufacturing and commercialisation.
Abingdon Health has a long track record of participating in successful grant-funded projects and has developed a good understanding of what is required to prepare a strong application.
The aim of this project is to develop a highly sensitive and specific assay with the ability to stratify mastitis by bacterial class (gram-negative or gram-positive). The test will provide professionals with a fast, on-farm decision-making tool for monitoring disease status and to aid antimicrobial treatment.
The mastitis rapid test development project started in April 2018 and will follow a path that will include:
- Reagent testing
- Selection and testing of materials
- Feasibility and Optimisation
- Full design history and technical files
Scale-up and large-volume manufacture
Once assay development is complete, scale-up will begin under a stringent verification and validation process. Following this stage, the test will be transferred into Abingdon Health’s high-volume automated manufacturing facility, which is ISO 9001 and ISO 13485 certified and works to the requirements of GMP.
For further details on how this part of the process is carried out read our case study on how we developed, manufactured and launched a lateral flow test for the rapid quantification of kappa and lambda free light chains.
Upon the completion of this project, the mastitis test will enter a regulated market. Therefore, Abingdon Health’s QARA team will compile and scrutinise the relevant project documentation in order to confirm assay performance, adhere to quality standards and prepare for market approval.
Abingdon Health has experience of working in a number of highly regulated industries. Read this case study to see how we entered a regulated market with a quantitative lateral flow rapid test.
Get updates about the progress of our mastitis test
Periodically, we will be providing updates on the progress of this project, join our e-mailing list to get these updates directly to your inbox.
What can Abingdon Health offer?
- Ability to apply reagents to a lateral flow device (LFD) or convert an ELISA assay into an LFD
- Aid the transfer from initial stage R&D into a full development and manufacturing project
- Cost-effective solutions with assay and customer requirements at the forefront
- Proven track record of developing and manufacturing qualitative, semi-quantitative, quantitative, single target and multiplexed assays
- A dedicated quantitative lateral flow assay development team
- Experience of working with different sample matrices
- Access to a quality and sustainable supply of reagents and materials
- Scale-up to High volume batches utilising state of the art manufacturing facilities
- Experience of working in regulated markets
- Academia-commercial collaboration