Service to conduct accelerated stability testing of diagnostic assays and medical products. Evaluates long-term performance and expiration dating for regulatory submission.
Manufactured by
Biofortuna Limited
Deeside, United Kingdom
Biofortuna is a contract assay development and manufacturing organisation (cdmo) providing a flexible and scalable outsourcing service to the sector’s leading in-vitro and point-of-care assay developers. Our services are wide-ranging, and whether we are supporting diagnostic companies, food safety experts or life science specialists our objectives are the same; to form long term partnerships and become a valued extension of your team. We do that by solving problems and presenting opportunities. We listen to your requirements, develop customised solutions and deliver them with openness and transparency. Our service portfolio includes: Genomic services, Cell banking services, Custom assay development, Lyophilisation, Contract manufacturing, Dispensing & kitting, Biobanking and ICH Stability storage. Operating from state-of-the art, humidity-controlled premises, and benefiting from ISO 13485 certification, ISO 17025 accreditation and FDA registration, they have a proven track record in the development and large-scale manufacture of PCR and LAMP molecular assays and Immunoassays.
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