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
Biofortuna is an expert provider of high quality IVD development and contract manufacturing services, with over 10 years’ experience and a strong track record in the development and manufacture of molecular and immunoassays. 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.
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
How lyophilised reagent beads can reduce waste
What are lyophilised reagent beads? Lyophilised reagent beads are durable ...
Read moreWelcome to the team Megan, Ish and Georgina
Megan, Ish and Georgina are the latest cohort of Laboratory scientists ...
Read moreFour tips to mitigate the risk of single source IVD assay manufacturing
How secure is your assay manufacturing? Manufacturing in vitro diagnostic (IVD) ...
Read moreSelecting the right contract manufacturer for in vitro diagnostic assays: your 12-point checklist
Increased throughput, improved efficiency, reduced risk There are many reasons ...
Read moreBiofortuna supports World Cancer Day
We are proud to support the UICC's World Cancer Day initiative ...
Read moreNew Whitepaper – Benefits of lyophilised beads for stabilising in vitro (IVD) diagnostic assays
Our scientific and marketing teams have just completed the finishing touches on ...
Read moreBiofortuna relocates to purpose built facilities and more than doubles its capacity
Biofortuna (Deeside UK), a specialist contract development and manufacturing ...
Read moreHow lyophilised reagent beads increase assay accuracy and speed to result
What are lyophilised reagent beads? Lyophilised reagent beads are durable ...
Read more