Development and Manufacturing

  • Abingdon Health has access to the latest, state-of-the-art technology and highly robust supply chains, as they work seamlessly on behalf of multiple customers. This enables greater access to quality materials and know-how, empowering customers to meet market demands. Abingdon Health can advise on commercialisation and sales strategies – helping to simultaneously increase revenues and market share, whilst lowering costs.

  • Lateral flow rapid test development can take several weeks or months to complete, it depends on several factors surrounding the assay and how it needs to perform, for example, does it need to be qualitative or quantitative?

    At Abingdon Health we establish timelines and deliverables following discussions between our lateral flow rapid test specialists and the client. These discussions are important for understanding our clients’ ambitions for the project and the test and forms the foundation for delivering a robust and reliable test.

    Abingdon Health determines several important considerations to create a development project schedule:

    • The sample matrix and target?
    • Are reagents available?
    • Is there quality and sustainable supply of reagents?
    • Does the assay need to be qualitative or quantitative?
    • Does the assay need to be single target or multiplexed?
    • Are there any regulatory considerations?

    More information about the process can be found on our lateral flow assay development page.

  • The time needed for lateral flow test strip manufacturing can vary depending on several factors:

    • What batch sizes are required and how often?
    • Is the assay qualitative or quantitative and single target or multiplexed?
    • Are there any regulatory labelling considerations?
    • What product packaging solutions are required?
    • Where do the devices need shipping?

    Abingdon Health produces detailed manufacturing schedules based on the assay specifications and the business needs of our customer. With multiple automated manufacturing sites, we can assure security of supply for routine manufacturing and meeting spikes in demand.

    For further details visit our manufacturing pages or contact us.

  • Abingdon Health has many years of experience developing and manufacturing rapid tests and readers in both regulated and non-regulated markets, both for our internal products and on behalf of service customers.

    Abingdon Health was responsible for launching a quantitative lateral flow test for multiple myeloma (blood cancer), and led the UK Rapid Test Consortium in developing and manufacturing a COVID-19 rapid antibody test.

    Abingdon Health is certified to ISO 13485 and ISO 9001 and works to GMP.

    Visit our quality standards page to learn more.

    Case study

    Abingdon Health led the development and manufacture of a rapid test that detects neutralising antibodies to SARS-CoV-2. The UK Government entered a contract with Abingdon Health to use the rapid test, which is called AbC-19TM.

    Read the AbC-19TM Whitepaper.

    To learn about our rapid test development and manufacturing services, click here.

  • Each lateral flow project is different and is dependent on the individual requirements of the assay, such as, does your test need to be:

    • Single target
    • Multiplexed
    • Qualitative
    • Semi-quantitative
    • Quantitative

    In addition to determining the above, it is also important to establish certain criteria to give an accurate cost estimation, such as:

    • Are reagents commercially available in a sufficient quantity or is there a requirement to source reagents?
    • Does your assay need to go through only some of the project phases or does it need to complete a full development and manufacturing project?
    • Is a rapid test reader required?
    • Is your assay entering a regulated market?
    • What sample matrices will be used?
    • Does the assay need to be in a dipstick or housed-cassette format?

    Abingdon Health is more than happy provide no obligation quotations and discuss your project needs under a non-disclosure agreement.

    Request a call or a quote for more information.

  • Working with a lateral flow assay development and manufacturing specialist such as ourselves means customers can call upon expertise and knowledge that is not available internally or use Abingdon Health as an extension of their in-house team to increase the chances of success.

    Abingdon Health can offer a complete integrated lateral flow and reader service to help minimise in-house operational risks and ensure smooth, efficient, and cost-effective project outcomes.

    Learn more about how our service can minimise risk:

    • We have invested in state-of-the-art equipment and expert personnel, and developed optimal processes and procedures, to assure the production of quality assays.
    • We have achieved ISO 9001 and ISO 13485 certification and work to the requirements of GMP. Having this in place demonstrates a Quality Management System that produces robust tests and assists customers in entering regulated markets.
    • Our Technical Transfer Team ensures full alignment between our assay development and assay manufacturing teams to ensure a smooth transition to scale-up.
    • We have experience of lateral flow reagent and material selection and have access to approved quality suppliers.
    • Our experienced reader team can work closely with you to ensure your quantitative assay meets your requirements and those of your customers.

    If you’re still wondering, is outsourcing assay development and manufacture risky? To put your mind at ease, our team is more than happy to explain how we approach each lateral flow assay project.

  • Outsourcing is an effective strategy for moving the capital off the balance sheet, without impacting your company’s ability to deliver on its business plan. The decision to outsource will enable your company more flexibility to increase production at short notice in response to your markets’ demands. By doing this,

    your business will be handing over the high costs of labour and equipment to your outsourcing partner, saving you time and money compared to the option to manufacture in-house.

  • Employee turnover can be high in some areas of life sciences. As a result, companies find their capabilities are significantly diminished over time, as employees gradually move on. Due to the expertise required to produce quality lateral flow rapid tests, Abingdon Health is continually recruiting rapid test experts and has implemented long-term development programmes to build a breadth and depth of manufacturing and development know-how. By outsourcing, you are gaining quick and on-demand access to these pools of experiences and specialist staff.

  • Outsourcing rapid test manufacturing lifts a major burden from any test owner or in-house manufacturer. As a result, teams can be freed to focus on driving the business forward by increasing output and revenue through a variety of ways. These ways include the development of new products and/or services, more time to identify and establish new partners or market opportunities, increased bandwidth to concentrate on the internal staff development and recruitment plans.

  • Reagent selection and sourcing is an important element in ensuring an assay development and manufacturing project is a success. It is also important to source reagents that are going to fulfil forecasted supply and demand? Also, do they meet cost requirements?

    Abingdon Health has access to a list of reagents from approved quality suppliers and can’t take away some of the time issues related to sourcing reagents.

    It is important to consider the following when looking for the most appropriate lateral flow immunoassay antibody or antigen:

    • Are reagents suitable for commercial use and can the suppliers provide a guaranteed supply of reagents and compatible raw materials?
    • Are reagents available exclusively? Is exclusivity important?
    • Are raw components from quality suppliers?
    • Understand the impact of material costs on final manufactured product costs.

Smartphone lateral flow reader: AppDx®

  • AppDx® uses the latest imaging technology to read lateral flow rapid tests and generate visual test line information that can then be managed in any number of data management opportunities through the phones User Interface (UI) and a connected dashboard.

    The home screen of the app provides users with a number of options and functions according the clients requirements.

  • Each project is very different and the cost will depend on the level of customisation, the complexity of the assay, and the regulatory requirements. A simple scoping exercise will allow us to provide an accurate quote.

  • We do not employ a ‘pay per download’ model, instead we have an annual service and maintenance contract that has a built in annual license fee. The cost depends entirely on the level of support required.

  • It is entirely down to the intended use of the App in conjunction with your rapid test and the functionality required. While the hardware is not considered a medical device in some cases the software could be considered as such. This can be established in the scoping exercise.

  • Each assay type is different and therefore AppDx needs to be set up to read each assay, which is part of the customisation work package. However, we can provide a demonstration of our standard AppDx version to demonstrate usability.

  • The app can securely transfer and retrieve test data, calibration information with customer’s cloud-based platform or web portal with varied authorised access levels.  Essentially the app provides authentication, using a registered email, to connect with an online service of the customer’s choice.

  • It will vary depending on the level of work required, it can be as short as 2-3 months for the customisation and adaptation of our standard AppDx® version or a little longer for unique build or more complicated solutions.

  • It is compatible with Android® OS and iOS® and therefore will work on all Smartphones utilising this platform.

  • Traceability is critical for a lateral flow test, therefore the app provides various methods to input such information. The app can scan test information from a barcode or a NFC (near field communication) tag. Users can also enter the information manually. The app can securely retrieve information from a short identifier using internet connectivity to a web portal.

  • Yes, if you want to apply custom logic and analysis algorithms on the test that can be accommodated during the development. A new method can be incorporated into the app even at a later stage, as an update or downloadable parameters.

  • The app can be used for dipstick as well as housed cassettes. A reusable placement accessory for dipstick-only tests is recommended. Each type of test needs to be separately optimised for your application.

  • In short Yes, however there are some considerations. There is a variation of camera characteristics from model to model and to a lesser extent even within same models.

    Due to the AppDx® program, a high degree of accuracy can be achieved and when external conditions affecting accuracy are controlled then quantitation can be achieved with good dynamic range.

    However, this is impacted with the more variability in external conditions, test performance capability and Smartphone capability. When looking to quantify, we recommend the introduction of specified Smartphones and minimum camera specifications. In many cases a shorter dynamic range of quantitation, or semi-quantitative implementation, is more immediately achievable. This can be identified early in the first stage of feasibility and development.

  • We will be happy to discuss an early stage program that establishes the viability of the platform in reading your test to the level required. This can be established in the scoping and including in your initial quote for feasibility.