The following example discusses an Abingdon Health product; however, this is representative of the quantitative lateral flow assay development process a contract services customer would follow with Abingdon Health.
Owing to Abingdon Health’s structure we were able to introduce Seralite®– FLC to market following an internal end-to-end assay and reader development and manufacturing process, which covered the following areas:
Abingdon Health developed, manufactured and launched Seralite® – FLC, a rapid diagnostic device for the simultaneous quantitative measurement of kappa (K) and lambda (λ) immunoglobulin free light chains (FLCs) in serum. FLCs are used as an aid in the diagnosis and monitoring of multiple myeloma.
Seralite® – FLC was commercially launched in April 2015 and since its inception, Seralite® – FLC has been registered in over 70 countries and is distributed globally by Abingdon Health’s partner, Sebia.
Seralite®– FLC’s uses highly specific, anti-K and anti-λ monoclonal antibodies (mAbs), which were developed by the University of Birmingham, and it was due to Abingdon Health’s close links with the university that created the opportunity to utilise the antibodies in Seralite®– FLC.
Director of Birmingham Clinical Immunology Service, Dr Mark Drayson, played a key advisory role in the development of Seralite® – FLC and in a series of videos he discusses some of this validation work and some of the advantages of using Seralite® – FLC.
The commencement of the Seralite® – FLC development project started by establishing a number of needs in the following areas:
In highlighting these areas it firmly established a whole range of requirements important to the assay, users and the market. These discussions formed the basis of the development project and allowed Abingdon Health to develop an action plan for approaching the following areas.
Our development, technical transfer and manufacturing teams work alongside one another from the outset of a project in order to call upon each other’s respective expertise. This ensures efficient communication of assay performance progress and maintains focus on achieving the desired user and market requirements for the assay.
Seralite® – FLC is a fully quantitative method and thus needed a lateral flow reader. To meet this requirement Abingdon Health developed the ADxLR5® Reader System.
The ADxLR5® Reader System was developed in tandem with Seralite® – FLC. The benefit of doing this was that both the interaction and compatibility of both technologies could be assessed simultaneously.
Like with the development of Seralite® – FLC, device and user requirements were established for ADxLR5® prior to commencing development.
In addition, customisation of ADxLR5®’s CE marked and FDA registered technology is available as part of Abingdon Health’s lateral flow reader customisation service. Not only this Abingdon Health has launched a Smartphone lateral flow reader App.
At the design freeze stage, Seralite® – FLC was scaled-up by Abingdon Health’s Technical Transfer team. This verification and validation phase was undertaken in order to assess how Seralite® – FLC’s performance would cope following the rigours of routine manufacture.
The process was successful and enabled Seralite® – FLC to be transferred into Abingdon Health’s lateral flow manufacturing facility, which is fully automated and is ISO 9001 and ISO 13485 certified and GMP compliant.
It is this use of state-of-the-art equipment that enables Abingdon Health to offer technical transfer and scale- up and routine lateral flow manufacturing to customers who require millions of tests per year.
With any medical device, there is a requirement for regulatory approval for the device and its labelling. Regulatory approval was managed by Abingdon Health’s QARA Team whereby they compiled, scrutinised and submitted the design files, technical files and market requirement specifications and product labelling.
In addition, shipping studies were carried out to test the robustness of the various components and outer packaging while in transit.
This has led to Seralite® – FLC being registered in over 70 countries.
Abingdon Health has experience of working in a number of the regulated industries and it’s this experience that has provided us with the knowledge and understanding of what customers require from an assay and reader development company.
Published 11th October 2018