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.

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Custom manufacturing

Flexible, FDA-registered, ISO 13485 manufacturing facilities allow us to provide everything from small-scale pilot batch manufacture to full commercial production.

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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.

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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.

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About 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.

Our products

Molecular diagnostic products

ampDRY™ master mix

Biofortuna is now offering its patent pending air drying technology, ampDRY™.

SSPGo™ HLA typing

SPGo is the ONLY single step ‘off the shelf’ SSP solution. The world’s first freeze-dried (lyophilised) HLA SSP delivers unique simplicity, accuracy and ease of use.

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Our clients

What our clients say

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