In the following article, we discuss 3 important elements that ensure an assay is manufactured in a way that meets market requirements.
Get the basics right
Successful lateral flow manufacturing involves; conjugating the labels and antibodies effectively as well as selecting and applying the right reagents, nitrocellulose membranes and absorption pads. Then assemble them into a lateral flow immunoassay (LFIA) and making sure they all interact with one another in order to deliver the desired outcome as outlined in the assay and market specifications. Simple...right!
The principle of lateral flow technology is simple. But, getting to the stage where the test is appropriate for use in the marketplace takes time, planning and a methodical development and manufacturing approach.
Successful Assay Scale-up
Taking a test from a prototype to a market-ready device is the next vital step. At this point, it’s important to manufacture batches of increasing quantities in order to validate and verify whether the scaled-up version of the assay meets the desired assay and market requirements.
Manufacturing in increasing batch sizes enables the assay development team to cross-reference scaled-up specifications with performance.
Automation ensures that devices are developed and manufactured to provide accurate results time and time again, with excellent inter and intra-batch reproducibility.
However, investment in state-of-the-art automated equipment comes at a cost. But, there is no need to incur equipment and subsequent personnel costs when commissioning assay development and manufacturing. In doing so, the time saved by not installing the equipment, training operatives and including the use of the equipment into standard operating procedures, allows a customer to concentrate on commercialising an assay.
All of the above means nothing without...
Ultimately, efficient lateral flow test development and having the necessary manufacturing resources results in producing the right product. However, there are 2 elements needed to bind all of the above together and they are simply expertise and experience.
Expertise ensures an assay is optimised and scaled-up efficiently for routine manufacturing and experience means tried and tested processes and procedures are utilised, regulatory considerations are taken into account, and market requirements are established and adhered to.
If you need an assay developing or are looking for a lateral flow manufacturing partner, speak with us. We offer:
- Secure pricing to aid your budget planning.
- Assay transfer efficiency under ISO-certified and GMP compliant lateral flow manufacture.
- A scaled-up manufacturing solution to allow you to meet your volume requirements.
Let our team show you how we can meet your quality, quantity and cost objectives. Contact us for more information.