Abingdon Health’s core expertise lies in the development, manufacturing and commercialisation of rapid lateral flow assay and reader systems.
Based on our proven lateral flow assay and reader technology we offer our academic and commercial partners a complete integrated solution including:
Lateral flow assay development and design
Technical transfer to manufacture
Lateral flow assay manufacture
Lateral flow reader design and development
We have experience in different markets including healthcare, veterinary, food and agriculture. Each lateral flow product we manufacture adheres to the regulatory standards necessary for that market.
Our manufacturing facility is certified to ISO 13485-2003 (including EN ISO 13485:2012) for the design, development and manufacture of lateral flow immunodiagnostic medical devices.
In addition, Abingdon Health’s manufacturing facilities are GMP compliant, with the U.S. Food and Drug Administration (FDA), for the design, development and manufacture of lateral flow devices, and device readers for in vitro diagnostic medical use.
Whether customers are looking to convert an ELISA assay into a lateral flow device (LFD), or are looking to apply a fully validated reagent to an LFD, Abingdon Health uses a comprehensive step-by-step approach to lateral flow assay development.
First of all, discussions will be held concerning the market requirements, product specifications, component supply and regulatory considerations. The output of these discussions will result in the completion of a product development plan which will incorporate all the phases required to take the product through to manufacture and then commercial launch. If we are also developing a lateral flow reader for you, we have these discussions at this point.
A number of different parameters will be evaluated during this first experimental stage of assay development. Abingdon Health will prepare a series of prototypes to be assessed against development goals at the end of these extensive studies.
The formulations, materials and processes used to make the working prototypes will then be optimised to ensure reproducibility.
Once design freeze is reached, the selected prototype needs to transfer from Research and Development (R&D) through to routine manufacturing.
At this point, our technical transfer team, with involvement from key members of our production team, will manufacture 3 batches of the product using high volume automated reel to reel machines. This stage is important for validating and verifying the performance of the assay.
The successful completion of an assay development project will result in the progression through to routine lateral flow manufacture.
Alternatively, if you have an existing lateral flow assay, with which you are looking for an assay manufacturing partner, Abingdon Health, undertake a full in depth review of the existing protocols prior to introducing into our routine manufacturing process.
Also, Abingdon Health has state of the art environmentally controlled manufacturing facilities with fully automated production capabilities including:
Non-contact jets for dispensing
Reduces the chance of cross-contamination during manufacture
Reel-to-reel web handling system for reagent spraying
Precision spraying to aid product accuracy and performance
Auto-laminator for assembly of membranes and other components
Removes human error and aids robust reproducibility
Lateral flow device packaging
Aids product stability owing to desiccated packaging
Automated dispensing of buffers
Ability to dispense multiple batches, quickly and accurately
Kit assembly and branded product packaging
Multi-sector and regulatory experience with established processes
In addition, our assay manufacturing service extends to foil packaging of each individual device as well as final kit assembly. Finally, as part of the service, we will offer guidance on labelling, scheduling and regulatory considerations irrespective of whether the customer decides to use our packing solutions or their own.
Finally, to find out more about our personalised lateral flow assay development and manufacturing services, please contact call +44 (0) 1904 406060 or email email@example.com