What is lyophilisation?

Lyophilisation is the process of freeze-drying your assay to prolong its life without the need for cold chain transportation and storage.

It is one of the best drying methods that is used in the for the preservation of many different heat-sensitive materials including: microbes, proteins, pharmaceuticals, plasma, and tissues.

The lyophilisation process involves removing water from a product to the point where it is no longer biologically or chemically active and offers a method of stabilising assays that contain heat sensitive components.

Biofortuna is a leading contract assay developer and manufacturer with a wealth of lyophilisation experience. We analyse your formulation to determine its characteristics and critical temperatures in order to design an optimal, efficient and cost-effective lyophilisation process.

Our lyophilisation services

Lyophilisation Contract Services

We offer our  lyophilisation expertise and experience to assay developers 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
Reduced labour, fewer consumables
Enhanced reproducibility and reliability
Decreased risk of contamination – less pipetting and elimination of multiple reagents

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

PCR reagents, Isothermal reactions, Proteins, Enzymes, Immunoassays can be stabilised into instantly soluble freeze-dried cakes or beads.

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

Download our information sheet here.


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

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

Lyophilisation 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.

Whitepaper: Freeze Drying – A Manufacturing Approach To Increase The Stability of In Vitro Diagnostic (IVD) Assays

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

Please enter your details below to access the white paper. Please be aware we may retain these details in order to send you the whitepaper and similar information in the future. You can unsubscribe from receiving this information at any time.

Why choose Biofortuna?

Biofortuna has leveraged over ten years of experience to create a sophisticated lyophilisation manufacturing process.

We partner with some of the world’s most innovative assay developers, supporting them to take their assays from concept through to commercialisation.

Do you have a project that we can help with? Contact us now to arrange an informal exploratory discussion.
I understand that Biofortuna will contact me and I will receive subsequent email updates (see Website Privacy Policy).