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In addition to manufacturing our own in vitro diagnostic test kits and assays, we provide consulting services for external companies including Product Development, Testing, Manufacture, OEM supply fulfilment all focused on supporting healthcare professionals and their patients.
We offer the following outsourcing services:
Importantly, we can offer an end-to-end service from Innovation and product development right through to manufacture and fulfilment.
We partner with companies that want to develop new in-vitro diagnostic tests or improve existing ones.
We have a team of experienced scientists, who innovate, develop, test and improve our own diagnostic assays. They are available to advise and create products for other companies on a consulting basis.
We worked with a customer to create a new set of tests, developing a microarray-based fluorescent immunoassay to allow simultaneous detection of multiple autoantibodies on a single patient. This is now branded and sold as AMiDot®.
The design involves a microarray printed on glass slides compatible with current IFA slides, that are able to be run on automated IFA processors at the same time as standard HEp2 and tissue IFA slides. Each slide tests for up to 20 different autoimmune antigens.
We worked closely with our partner to develop the best solution, and now manufacture this for them (see contract manufacturing).
We enabled research, development, testing and clinical validation of the new diagnostic test to the point where it was ready for sale.
Using our team and facilities to manufacture your product.
We work with partners to manufacture their products for them, where suitable, at our manufacturing facility in Ely, Cambridgeshire, UK. Our facilities are fully accredited as ISO 13485-2016 Management Systems.
We continue our relationship with our partner following R&D of the AMiDot® microarray product, which is manufactured at our facilities.
We are happy to discuss requirements with other companies looking to outsource their manufacturing.
