Medical tests manufacturer launches analytical laboratory
Abingdon Health, a medical device contract development and manufacturing organisation (CDMO), has opened an analytical laboratory at its Doncaster facilities.
The laboratory will be operated by the York-headquartered company’s wholly-owned subsidiary, Abingdon Analytical Ltd.
The group has been providing analytical laboratory services since 2023 as part of its strategy to offer a comprehensive CDMO service that supports its customers in bringing products to market.
The services of an analytical laboratory make a significant contribution to a product’s regulatory technical file, including product stability testing, specificity, sensitivity, assessment of detection limits, interference, cross-reactivity testing, and method comparisons.
The technical file is a key requirement for regulatory approval by FDA, EU IVDR, UKCA and other regulatory authorities.
Abingdon Analytical Ltd will provide its services for the lateral flow testing market and for adjacent sectors, such as other immunodiagnostic products and molecular diagnostics.
The group is investing up to £1m of the proceeds of a recent placing to strengthen its analytical laboratory service, part of which has financed this opening.
Dr Chris Hand, executive chairman of Abingdon Health, said: “This next step in our expansion provides a comprehensive analytical services laboratory, forming a bridge between our CDMO and regulatory service offerings, and linking our group companies, Abingdon Health, IVDeology and CS (Life Sciences).
“The capability to generate analytical and product performance data for use in a product’s regulatory technical file adds another element to the broad portfolio of services we offer our customers.”
