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 Contract Services
Biofortuna offers its freeze-drying (lyophilisation) 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:
We offer Freeze Drying Microscopy 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.
Download our information sheet here.
We also have a range of custom PCR mastermixes which are optimised for freeze drying. :
Freeze-dried kits are ideal for multiple molecular diagnostic applications including:
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:
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.