Abingdon Health’s core expertise lies in the development and manufacturing of rapid lateral flow immunoassay and reader systems. Owing to this expertise, we offer a bespoke lateral flow assay development service that is tailored to your needs.
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 and readers.
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.
Planning, Feasibility and Optimisation
Lateral Flow Assay Development
Whether customers are looking to convert an existing ELISA assay into a lateral flow device (LFD), or are looking to apply a reagent to an LFD, Abingdon Health uses a comprehensive step-by-step quality-driven approach to lateral flow test development.
Our experience in lateral flow diagnostics means we are able to develop assays for different sample matrices including saliva, serum, plasma, blood, urine, milk, plant material and much more.
Concept and planning phase
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 will have these discussions in parallel.
Assay feasibility and optimisation
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. For example, the optimal quantity of capture antibody will be determined.
Following client approval of the final assay specification, the assay is classed as having reached design freeze and no further modifications are made.
Abingdon Health can carry out a full search for commercially available reagents in order to fulfil lateral flow assay development. To ensure selection of the most appropriate reagents we work with a number of suppliers.We consider the following elements when talking with suppliers:
Exclusivity – Would the supplier consider an exclusive supply agreement for a minimum purchase?
Guaranteed supply – Will supply be sufficient for assay development and future market requirements?
Original manufacturer – Are they the producer of the reagent and are there any restrictions on usage?
Sometimes reagents are not commercially available or sometimes our clients prefer to have full control of supply by having their own reagents. Therefore, we can also help with:
Antibody and antigen generation
A number of our suppliers can generate antibodies and antigens, some of which can be available in as little as 10 weeks.
Growth and maintenance of cell lines
We work with partners who can provide bulk production of cell lines quickly and efficiently. In addition, they can provide purification services and secure cell banking.
Read more about our reagents selection process to see how we approach this service.
Multiplexed Lateral Flow Assays
At Abingdon Health we offer the development and manufacture of both single target assays and multiplexed assays. In addition, we offer a quantitative multiplexed option by incorporating our CE marked and FDA registered reader technology.
Our approach to developing multiplexed lateral flow assays follows the same process of planning, feasibility and optimisation as documented above.
Contact us to learn more about multiplexed lateral flow assay development.
Sample Types for Lateral Flow
Depending on the target in question or market requirements will depend on which sample type needs to be used to detect a target analyte.
Lateral flow devices are versatile enough to be developed to detect target analytes in sample matrices including:
- Whole blood
- Tissue samples
- Animal feed
- Plant material
Contact us to learn more about how we can help develop an assay to work with one of the sample types above.
Typically, lateral flow assays utilise conjugated colloidal gold, carbon, or coloured latex nanoparticles within the conjugate pad. Other labels include magnetic or fluorescent beads.
Labels will be chosen during lateral flow assay development depending on several factors such as the target, sample matrix and antibody. The optimisation of the assay will ensure the label interacts correctly with the antibody and antigen to ensure efficiency and accuracy of results.
In order to maximise the efficient use of labels in assays, we have partnered with Innova Biosciences, who have many years experience of lateral flow assay labelling and conjugation.
Lateral flow manufacturing
Once design freeze is reached, the selected prototype needs to transfer from Research and Development through to routine manufacturing.
At this point, our technical transfer team, with involvement from key members of our production team, will typically 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 following scale-up.
To learn more about our manufacturing capabilities please visit our lateral flow manufacturing page.
Lateral flow immunoassays have enabled testing to move from the laboratory to the point of contact. Providing results in minutes, these rapid tests are straightforward to use and have found wide application.
Lateral flow devices (LFDs) use immunoassay technology via a combination of antibodies (or other binding moieties such as aptamers and affirmers), nitrocellulose membranes and coloured nanoparticles in order to produce qualitative (visual) results or quantitative results in combination with reader technology.
Read how we combine lateral flow and reader technology in order to produce quantitative assays.
To find out more about our lateral flow assay development and lateral flow manufacturing services, please call on +44 (0) 1904 406060 or email firstname.lastname@example.org with an outline of your requirements. If you would like a quotation for our service please visit our quotations page.