Custom 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.
Contract 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





& pharmaceutical



About Biofortuna
At Biofortuna our mission is simple:
To help our partners increase the quality and availability of diagnostic and detection testing.
We partner with some of the world’s most innovative assay developers supporting them to take their assays from concept through to commercialisation rapidly and cost effectively.
A combination of technical expertise, ISO13485 accreditation, FDA registration and state-of-the-art facilities mean our Customers can rely on the highest scientific standards and a culture of problem solving and project delivery. More
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 supports World Cancer Day
We are proud to support the UICC's World Cancer Day initiative ...
Read moreBiofortuna shortlisted for 2020 Bionow awards.
We are delighted to share the news that we have been shortlisted for the 2020 ...
Read moreBiofortuna sets a new production record.
Biofortuna sees record production levels across November and December ...
Read moreBiofortuna appointed as CMO for QuantuMDx CE–marked assay
Biofortuna has provided assay development and manufacturing support to ...
Read moreCoronavirus Update from Biofortuna
In light of the current situation with COVID-19, we would like to take this ...
Read moreBiofortuna unveils ampDRY™ air-dried master mix
Biofortuna (Liverpool, UK) – the international IVD contract research and ...
Read moreBiofortuna closes £1.6M funding round
Biofortuna Ltd, a UK-based diagnostics company offering molecular diagnostic ...
Read moreBiofortuna expands its immunoassay development and manufacturing services
Biofortuna is expanding its IVD service portfolio to provide a greater focus on ...
Read more