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FAQs

All the answers to your questions about Abingdon Health's development and manufacturing services.

Development and Manufacturing

The frequently asked questions about our lateral flow test development and manufacturing services.

  • 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.

    Read our blog about working with a lateral flow test contract manufacturer to learn more.

  • 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 considers the following 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 our capabilities 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 use with multiple myeloma patients (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 IgG neutralising antibodies to SARS-CoV-2 called AbC-19TM.  The solution, combines with an easy to use app to produce an antibody certificate and confirms if individuals have developed IgG neutralising antibodies following COVID-19 infection or vaccination.

    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 when calculating lateral flow test manufacturing costs. For example:

    • 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?

    With this information, an accurate quote can be formulated. 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 R&D and manufacturing specialist means customers can use expertise and knowledge that may not be available internally.

    Abingdon Health offers rapid test product development, regulatory support, technology transfer, reader, and manufacturing services for customers looking to develop new assays or transfer existing tests to a new or second manufacturer. We  help minimise in-house operational risks for our clients and ensure efficient 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.

    Read our blog about the benefits of partnering with a lateral flow test contract manufacturer to learn more.

    Alternatively, 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.

    We explain more about this subject in our blog ‘The benefits of partnering with a lateral flow test contract manufacturer‘

  • 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 and quality 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.