Freeze drying

Freeze-drying (lyophilisation) is becoming increasingly popular with IVD test manufacturers looking to simplify assay handling and processing.

Biofortuna is a leading supplier of freeze-dried tests, and has a wealth of expertise in transforming molecular diagnostic reagents into instantly soluble freeze-dried pellets or beads.

This white paper outlines the various steps of the lyophilisation process, the potential challenges, and the strategies which can be used to overcome them.

Freeze Drying White Paper

Freeze Drying Contract Services

Biofortuna offers it’s proprietary freeze-dried (lyophilised) expertise, and specially formulated cryo-preservatives and lyo ready PCR mastermixes as an ISO13485 contract development and manufacturing service.

This proprietary service can be applied to your molecular reagents resulting in:

Simple one step protocols – Just add sample and go
Enhanced ambient temperature stability – No fridges, freezers or ice shipping
Instant pellet solubilisation – No vortexing or pipette mixing
Quick and easy – Reduced labour, fewer consumables
Enhanced reproducibility and reliability
Decreased risk of contamination – Less pipetting and elimination of multiple reagents

We offer Freeze Drying Microscopy analysis to analyse your assay mix to allow the optimisation of freeze drying protocols.

PCR Reagents, Isothermal reactions, Proteins, Enzymes, Immunoassays can be stabilised into instantly soluble freeze-dried pellets.

The result: simple, stable and long lasting kits for easy transport and storage at room temperature.

The Biofortuna Service’s flyer can be downloaded here.

We also have a range of custom PCR mastermixes which are optimised for freeze drying. :

Glycerol free (lyo ready) hot start mixes
Glycerol free (lyo ready) Taq, reverse transcriptase, BST and UNG

Freeze-dried kits are ideal for multiple molecular diagnostic applications including:

Companion diagnostics
Clinical testing


Food and veterinary

Our state of the art dedicated laboratories and production facilities are ISO 13485 certified for the production of IVD kits. Together with our R&D facilities we can offer a complete assay design and development and validation and manufacturing service.

Design, development & validation of mixes and IVD kits
Manufacture and packaging of kits and reagents
OEM mixes and tests
Suitable for multiple molecular technologies
Plastics compatible with machines of your choice: 8 well strips, multi well plates, POC cartridges, microfluidic devices
Regulatory assistance and submissions
Enhanced stability of reagents at ambient temperatures

Freeze Drying Analytical Services

In order to deliver the highest possible freeze dried performance of your mix, Biofortuna offers freeze-dried microscope analysis. The freeze-dried microscope analysis allows us to do the following product optimisation:

Identification of critical freeze-drying parameters such as Tc and Tg points.
Develop lyophilisation protocols to fit your product.
Optimise reagent formulations to identify the ideal combination of cryo-preservatives, lyophilisation protocol and reagent performance.
Identify key information for manufacturing processes.

This can be used with our Molecular Assay Design and Development Service to optimize your assays and reagents.

Pictures 1 & 2 show typical images from our FDM system.

Picture 1 – A glycerol free mix is frozen (e.g -40°C). The vacuum is then applied to initiate drying. A drying (sublimation) front moves across the sample as water is removed. The sample temperature is then slowly increased.

Picture 2 – Temperature is reached when the sample cannot hold its structure without water present. As water is removed the sample ‘collapses’. The example above shows a collapse onset temperature of -27°C and a complete collapse at -25°C. The primary drying should be performed 2-8°C below the onset of collapse.

Contact us to discuss how we can make a difference to your products. The service is customised to match your needs.

Do you have a project that we can help with? Contact us now to arrange a meeting...