CASE STUDY

In addition to developing and manufacturing rapid lateral flow tests for our clinical and contract customers, Abingdon Health manufactures a range of rapid tests for plant diseases called Pocket Diagnostic®.

The following areas are discussed to highlight how Pocket Diagnostic® was brought to market in order to help fight devastating plant diseases.

  • Assay development
  • Scale-up
  • Manufacture

Assay development

Pocket Diagnostic® was initially developed for use by the UK Government Plant Health Inspectors in order to provide them with a cost-effective and user-friendly, in-field rapid testing solution. Knowing the Pocket Diagnostic® range would need to test a variety of plants and plant material the tests were enhanced to work with a variety of sample matrices such as leaf and woody plant materials.

With this in mind, the team followed a development plan that covered the following areas in order to ensure the tests worked with the intended matrices.

  • Reagents testing
  • Selection of membranes, samples pads, buffer selection
  • Feasibility, optimisation and scale-up
  • Validation

Scale-up and large volume manufacture

Following assay development, the Pocket Diagnostic® range was scaled-up via a verification and validation phase in order to assess how Pocket Diagnostics performance would cope with the rigours of routine manufacture.

Pocket Diagnostic® is manufactured at Abingdon Health’s  automated and climatically controlled lateral flow test manufacturing facility, which is ISO 9001 and ISO 13485 certified and works to GMP requirements.

Since its launch, Pocket Diagnostic® has been used by a global audience across 6 continents and has provided professionals working in horticulture, forestry and food production with an in-field rapid testing solution for pathogens such as Phytophthora spp*, Potato virus Y, Erwinia amylovora (Fire Blight) and Ralstonia solanacearum (Brown Rot/Bacterial Wilt).

To learn more about Abingdon Health’s services, there are a series of videos which can be viewed by visiting https://www.abingdonhealth.com/videos/.

Why work with Abingdon Health?

  • Transfer new and existing manufacturing Standard Operating Procedures into routine manufacture
  • Troubleshoot test performance and optimise test recipes and specifications
  • Scale-up from bench-top to automated manufacture
  • Navigate complex regulatory, legal, and commercial barriers to launching products to market
  • Card and test strip manufacture through to assembled devices and kitting
  • Low, medium and high-volume automated manufacture across multiple sites
  • Scalable solutions in line with growth plans
  • Adaptability in response to spikes in demand
  • Stable pricing for budget planning
  • International shipping and supply chain management
  • In-house regulatory and commercialisation support
3 lateral flow scientists using high volume lateral flow manufacturing equipment

Whether you are an established player or emerging innovator, a good lateral flow test contract manufacturer will guide you through the outsourcing process, while being an extra pair of eyes for scoping opportunities and a safety net in supporting success. Contact Abingdon Health to see how help you on your journey.

*The Pocket Diagnostic® Phytophthora test detects species such as P. ramorum (Ramorum Blight/Sudden Oak Death), P. infestans (Late Blight, the causal pathogen of the Irish Potato Famine), P. kernoviae, P. lateralis, P. cinnamomi and P. cactorum.

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