Lateral Flow Development at Medtechtomarket
Lateral Flow development is a multi-stage process from initial idea to a market-ready product, and one in which here at Medtechtomarket we are well versed in – A lot of diagnostics development in our in-house facility is lateral flow development.
Our ISO 13485:2016 certification ensures that we have an effective and robust quality system in place to achieve successful lateral flow development. The development and manufacturing process can seem complicated. Find out the stages involved below.
The Key Stages of Lateral Flow Development
1. Proof of Concept & Optimisation
The scientific foundation, or core chemistry of each lateral flow test has to be developed to ensure the assay consistently meets the requirements of the desired product. The reaction between antibodies and the target analyte must be optimised to minimise variations. Critical choices around material selection must also be made at this stage of lateral flow development. The goal is to achieve high on-rate (binding efficiency), low off-rate (releasing efficiency), and low cross-reactivity.
2. Scale up & Design Freeze
Progressing from producing low volumes of lateral flow tests in a laboratory or R&D environment, to much larger volumes using the equipment that will be used to manufacture the final product means that all formulations, manufacturing processes, and quality control specifications have to be finalised, in a ‘design freeze’.
3. Verification & Validation
Another key stage in the lateral flow development process is verification and validation (V and V). A prototype of the lateral flow test, made to the exact specifications of the final product is tested to obtain objective data demonstrating that the design requirements have been met. All regulatory submissions (where appropriate) are also included at this stage. Verification shows that the manufacturing method is robust and that results are consistent for the intended use.
4. Launch & Ongoing Development
Depending on the assay type and market requirements, the lateral flow test will need to be appropriately packaged and labelled, with any instructions for use also included. The product will then be ready for a CE mark or similar. The necessary regulatory documents submitted to the appropriate authorities will ensure the lateral flow test is ready for launch and can move into a high-volume manufacturing process.
Outsourcing Lateral Flow Development
Medtechtomarket is here to help at every stage of the lateral flow development process. We transform ideas into market-ready products at our ISO 13485:2016 accredited labs and manufacturing facility – all under one roof to keep your project moving seamlessly.
Outsourcing to us saves time, costs, and reduces risk. We are your flexible partner for full turnkey outsourcing or tailored support where you need it most.
Get in touch today to discuss your next project.