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In vitro diagnostic (IVD) assay development

Deeside, United Kingdom

Contract development and manufacturing services for in vitro diagnostic assays, including DNA extraction, assay formulation, and customizable dispensing, kitting, and labeling. Supports clinical diagnostic innovation from development through manufacturing scale-up with temperature-controlled storage...

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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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