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
Once 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:
- Contact 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
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.
We have experience manufacturing lateral flow rapid diagnostics for customers across the UK, Europe, USA and the rest of the world. To find out more about our personalised lateral flow manufacturing services, please contact one of our colleagues 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.
Download our Development & Manufacturing Brochure
Download a copy of our Lateral Flow Reader OEM eBook