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 and ISO 13485 certified manufacturing facilities allow us to provide everything from small-scale pilot batch manufacture to full commercial production.
Lyophilisation
Our proven lyophilisation expertise enables 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.
Genomic Services, Assay Development and Contract Manufacturing
Areas of expertise
Clinical diagnostics
Genomic research
Animal health
Food & drink safety
Consumer health& pharmaceutical
Environmental
Bio threat detection
Drugs of abuseAbout 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 diagnostic companies supporting them to take their assays from concept through to commercialisation rapidly and cost effectively.
A combination of technical expertise, ISO 13485 and ISO 17025 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
News and blogs
Ten reasons to outsource assay manufacture
If you have always manufactured your in-vitro diagnostic (IVD) assays ...
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Lyophilising or Air Drying. Which is better for my assay?
Whether you are lyophilising or air drying your assay, your ultimate ...
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Re-defining the limits of single batch assay stabilisation
In response to increasing demand for stabilised molecular diagnostic ...
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Four tips to mitigate the risk of single source IVD assay manufacturing
How secure is your assay manufacturing? Manufacturing in vitro diagnostic (IVD) ...
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How lyophilised reagent beads increase assay accuracy and speed to result
What are lyophilised reagent beads? Lyophilised reagent beads are durable ...
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How lyophilised reagent beads can reduce waste
What are lyophilised reagent beads? Lyophilised reagent beads are durable ...
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Selecting the right contract manufacturer for in vitro diagnostic assays: your 12-point checklist
Increased throughput, improved efficiency, reduced risk There are many reasons ...
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Biofortuna supports World Cancer Day
We are proud to support the UICC's World Cancer Day initiative ...
Read moreWhat 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.”
