In addition to lateral flow assay development, Abingdon Health offers automated lateral flow manufacturing with the capacity to manufacture millions of rapid tests annually.
An assay can enter into routine manufacturing 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.
Abingdon Health’s manufacturing facility in York, UK, is certified to ISO 13485:2003 (including EN ISO 13485:2012) and GMP compliant. Our state of the art environmentally controlled manufacturing facilities offers fully automated production capabilities including:
Non-contact jets for dispensing
Reduces the chance of cross-contamination during manufacture
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
The requirement to transfer manufacturing of your existing lateral flow assay may be as a result of:
Outgrowing your in-house lateral flow manufacturing capacity
A need to reduce variability by employing a single manufacturing site
A requirement of a second manufacturing partner to aid market entry in a new territory or manage risk
Assay development completed by another partner
Regardless of the route, Abingdon Health can undergo a technical transfer program to take the assay through the necessary stages leading to onward routine manufacture in our facility.
In communication with our customer, design specifications, regulatory requirements and the final kit assembly will be reviewed. Abingdon Health will manufacture a pilot batch in order to cross reference performance with design freeze specifications. Following this stage, we will typically manufacture three validation batches on our automated equipment as part of scale-up to routine manufacture.
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 email@example.com with an outline of your requirements.