Lateral flow rapid test development at Abingdon Health typically follows a number of stages with formal reviews at critical points. The same structure is used whether the product development is being performed on behalf of a customer (contract assay development) or it an ‘in-house’ product development. Within this structure, there is a degree of flexibility and modularity allowing development programs appropriate to each of the diverse projects undertaken by Abingdon Health.
Having an effective and robust Quality System, in Abingdon’s case ISO 9001:2015 & ISO 13485:2016, is one of several key elements to achieving successful lateral flow assay development.
It is highly desirable that for any contract or collaborative work, the R&D team at Abingdon Health are in regular contact with our partners, and we will arrange frequent and regular calls and/or meetings to provide updates and discuss progress.
This stage of product development is subdivided into 3 phases: Proof of concept, Optimisation and characterisation and Scale-Up and Pre-verification.
The aim of this stage is to ascertain that a test is feasible in the desired format, and in the case of contract development work will make use of and build upon the knowledge previously generated by the customer.
One of the most important aspects early in a project is to clearly define the objective and to produce a detailed Product Requirement Specification. Another key aspect of this stage is the identification and evaluation of key raw materials such as antibodies and antigens. As set out in a recent interview answering the question: What are the 3 key elements of lateral flow assay development?
The aim of this stage is to further develop the assay so that it consistently and reproducibly meets the product requirements. The effects of each of the assay components (including interactions between them) are examined to identify the optimal combination and minimise variability.
The aim of this stage is to start scaling-up the product from low volumes produced on R&D equipment to much larger volumes produced on the equipment that will be used for manufacturing the on-market product. The product is also tested to provide confidence that key product requirements will be met, before proceeding to the later stages.
Successful completion of this stage results in ‘Design Freeze’ where the formulations and manufacturing procedures have been finalised.
Verification studies are performed on a product that is made to the final manufacturing methodology and provides objective data demonstrating that the design requirements have been achieved and supporting product claims (including regulatory submissions where appropriate).
Validation studies are performed to ensure that the final manufacturing method is robust and consistently results in a product that meets specifications and is suitable for the intended use.
Once complete the rapid test can progress in to routine, high-volume manufacture.
Following successful completion of verification and validation, the final activities necessary for moving towards and product launch need to be completed. Dependent upon the assay and market requirements these may include activities such as finalising product labelling and Instructions for Use, CE marking the product or preparing documentation to submit to regulatory authorities.
Abingdon is a fully integrated assay and reader development and manufacturing business working via the ISO13485 quality management system with contract manufacturing facilities operating to GMP and registered with the FDA.
We have extensive experience at developing single target and multiplexed qualitative and quantitative lateral flow tests across a variety of industry sectors. If you are currently looking for a lateral flow development partner, please contact us on +44 (0) 1904 406082 or [email protected] to learn about how we help you achieve your assay ambitions.