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