Assay development
Our dedicated team can develop your immunoassays and molecular diagnostic tests to meet your specific needs. We can then prepare them ready for manufacture.
Custom manufacturing
Flexible, FDA-registered, ISO 13485 manufacturing facilities allow us to provide everything from small-scale pilot batch manufacture to full commercial production.
Freeze drying
Our proven lyophilisation expertise and proprietary cryo-preservatives enable us to transform virtually any diagnostic reagent into an instantly soluble freeze-dried format.
Dispensing and kitting
Working to ISO 13485 and FDA CFR21 part 820 compliant quality systems, we can dispense, assembleand package diagnostic assay kits, ready for shipment to your customers.
Our Services
Areas of expertise
Clinical diagnostics
Genomic research
Animal health
Food & drink safety
Consumer health& pharmaceutical
Environmental
Bio threat detection
Drugs of abuseAbout Biofortuna
Biofortuna is an expert provider of high quality IVD development and custom manufacturing services, with over 10 years’ experience and a strong track record in the development and manufacture of molecular and immuno assays. The Company and its scientific leadership team have the expertise and infrastructure to quickly and efficiently take an assay all the way from initial concept up to manufacture of a ready-to-market kit.
Proprietary stabilising technology and humidity controlled facilities enable Biofortuna to produce easy to use, single-step setup diagnostic kits that address complex issues, especially when working with difficult controls or reagents.
Biofortuna also supplies a portfolio of in-house developed products that provide stable, easy-to-use solutions for molecular diagnostic and immunoassays.
Biofortuna now offers a comprehensive range of genomic services.
Our clients
What our clients say
“Biofortuna’s personalized attention sets them apart…”
“We have been very happy with the technical transfer process and ELISA manufacturing service provided by Biofortuna”
“Biofortuna Limited have been our sub-contract manufacturer of the Arcis range of sample preparation kits since the technology was first commercialised. Their technical team has been quick to understand our technology and where issues have arisen, Biofortuna have been adaptable in identifying solutions which meet both product quality and delivery targets. Their support and flexibility during our acceleration phase is appreciated.”
Company news
Biofortuna appointed as CMO for QuantuMDx CE–marked assay
In light of the current situation with COVID-19, we would like to take this ...
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Coronavirus Update from Biofortuna
In light of the current situation with COVID-19, we would like to take this ...
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Biofortuna unveils ampDRY™ air-dried master mix
Biofortuna (Liverpool, UK) – the international IVD contract research and ...
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Biofortuna closes £1.6M funding round
Biofortuna Ltd, a UK-based diagnostics company offering molecular diagnostic ...
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Biofortuna expands its immunoassay development and manufacturing services
Biofortuna is expanding its IVD service portfolio to provide a greater focus on ...
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Biofortuna FDA Inspection Completed Successfully
Biofortuna have successfully completed an FDA site inspection to retain their ...
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Record year for Biofortuna Contract Services division
Biofortuna Ltd is pleased to announce a record year of growth for its IVD ...
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Biofortuna invests in climate control facilities
Biofortuna Ltd, a diagnostics company based in Wirral UK, announces significant ...
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