Welcome

Biofortuna is a leading diagnostics company offering both custom IVD development & manufacturing services and molecular diagnostic products. Being ISO13485 certified and FDA registered, we are your partner of choice for IVD immunoassay and molecular diagnostic development & manufacture. We also specialise in freeze-drying diagnostic products enabling complete PCR reactions and immunoassay reagents to be transformed into stable pellets.

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Experts in Freeze Drying

Using proprietary freeze drying technology, expertise and experience, we can lyophilise your complete PCR reactions and immunoassay reagents, to be stable at ambient temperatures.

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Immunoassay Development and Manufacture

We offer IA development and a complete ELISA plate coating, vialling and kitting manufacturing service within our ISO13485 certified and FDA registered site.

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Molecular Diagnostic Products

Biofortuna offers a range of freeze dried, CE marked and FDA approved PCR kits, for the HLA disease association market. These kits only require the end user to add DNA prior to amplification and detection, offering unique simplicity, accuracy and ease of use.

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Custom IVD development and manufacturing services


Design and 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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Manufacturing

Flexible, FDA-registered 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 pellet.

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Dispensing and Kitting

Working to ISO 13485 and FDA CFR21 part 820 compliant quality systems, we can dispense, assemble and package diagnostic assay kits, ready for shipment to your customers.

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Molecular diagnostic products


SSPGo™ HLA typing

SSPGo 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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ReadyPlex™ Blood group genotyping

We are currently developing a comprehensive range of qPCR blood grouping kits. The kits will be designed for ease of use, accuracy and speed.

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News

Biofortuna Ltd, a UK-based diagnostics company offering molecular diagnostic products and contract manufacturing services, has raised £1.6M

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Events

Biofortuna will be attending BioTrinity in London 23rd-25th April 2018. Contact us now to schedule a meeting

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