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lateral flow assay development planning test strip reagent sourcinglateral flow feasibility & optimisation

 

 

 

 

In addition to lateral flow assay development, Abingdon Health offers automated lateral flow manufacturing with the capacity to manufacture millions of rapid tests annually. Working with customers across multiple sectors, Abingdon health can tailor manufacturing specific to assay and customer requirements.

A lateral flow assay can enter into routine manufacturing with us either directly following the successful completion of an assay development project or as a result of a successful technical transfer of an existing assay in the market which is being manufactured elsewhere.

Transfer to manufacture

lateral flow assay card manufactureOnce design freeze is reached following assay development with us or another partner, 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.

Routine lateral flow manufacturing

Lateral Flow Manufacturing

Once an assay has progressed into routine manufacture we will be firmly focused on helping our customer to meet market goals. Therefore, we work in collaboration with customers to address the following:

  • Batch sizes and manufacturing forecasts to meet market launch and on-going requirements
  • Explore and plan packaging and labelling solutions
  • Establish a timetable of manufacturing deliverables

Abingdon Health’s manufacturing facility in York, UK, is certified to ISO 13485:2003 (including EN ISO 13485:2012) and GMP (Good Manufacturing Practice) compliant. We offer automated production capabilities in high throughput state of the art environmentally controlled manufacturing facilities.

We are able to offer a variety of lateral flow manufacturing capabilities including:

  • Image of lateral flow assay development and manufacture facilityContact and non-contact jets for dispensing
    Flexible approach to dispense in accordance with desired parameters
  • 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


Manufacturing of quantitative lateral flow assays

Manufacturing of quantitative lateral flow assays

Owing to Abingdon Health’s experience, we are able to offer routine manufacturing for both qualitative and quantitative assays.

Read how we combine lateral flow and reader technology in order to produce quantitative assays.

Finished products

Lateral flow manufacturing including final product packaging Our assay manufacturing service extends to foil packaging of each individual device as well as final kit assembly.

We can also offer guidance on labeling and regulatory considerations.

Transferring manufacture of an existing assay

We provide manufacturing services for tests that have successfully completed a lateral flow assay development project or that are already in the market but are being manufactured elsewhere.

Visit our lateral flow test manufacturer page to see how we can help.

What to expect as an Abingdon Health customer?

Abingdon Health is dedicated to providing every customer with high levels of customer service. We understand that every lateral flow assay project is different and market goals vary. Learn more about our personalised service to our customers.

To find out more about our personalised lateral flow assay development and lateral flow manufacturing services, please contact one of our colleagues on +44 (0) 1904 406060 or email info@abingdonhealth.com with an outline of your requirements. If you would like a quotation for our service please visit our quotations page.

Abingdon Health Lateral Flow Assay Contract Services Brochure downloadDownload our Development & Manufacturing Brochure

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lateral flow assay reader oem and manufacturing lateral flow devicesDownload a copy of our Lateral Flow Reader OEM eBook

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