What are lyophilised reagent beads?

Lyophilised reagent beads, or ‘lyo beads’, are spheres of customisable, lyophilised material.

Unlike traditional lyophilised formats, each individual bead contains a single, accurately measured dose. By ensuring dose consistency, the potential for variance is eliminated, improving assay accuracy.

Lyo beads will also allow you to:

Lower risk of contamination
Increase efficiency with quicker speed to result
Reduce errors by providing a ready-to-use assay
Lyo beads in containers
Lyophilsed reagent beads being shaped in liquid nitrogen

What is lyophilisation?

Lyophilisation is also known as ‘freeze drying’. This is a low temperature dehydration process which freezes a product, lowers the pressure and removes the ice by sublimation.

Lyophilisation works in four stages:

    1. Pre-treatment – revising the formulation to boost stability, improve appearance or enhance the processing.
    2. Freezing and annealing (the most important stage) – the product is cooled below its triple point (the lowest temperature at which the material’s solid, liquid and gas phases can co-exist).
    3. Primary drying – pressure is lowered, heat is applied – causing the ice to sublime, removing 95% of the water. This phase is slow; it can take several days. Rushing it by adding too much heat can alter the structure of the material. Applying a partial vacuum will speed up sublimation and drying.
    4. Secondary drying (at higher temperatures) – to remove unfrozen water molecules. An inert gas is then used to break the vacuum. The material/product is then sealed.

You can find out more about the lyophilisation process here. 

 

Why is lyophilisation used for assay development?

Lyophilisation provides a convenient and reliable method for long-term assay storage, as well as preserving their activity without disruption.

Other key benefits include:

Enhanced stability
Quick and easy dissolution of reconstituted products
Reduced transportation costs, removing the need for a cold chain and temperature-controlled storage
Reduced weight and volume of assays, minimising shipping costs and environmental impact
Reduced risk of spoiling as a result of mismanaged temperatures during transportation and storage

You can read more about the advantages of lyophilisation for assay development here.

Lyophilised PCR reagent beads

When to use lyophilisation instead of air drying

Whether you are lyophilising or air drying your assay, your ultimate goal is to stabilise it for transport and storage at ambient temperature without loss of functional performance.

Both processes involve the removal of water to achieve this and enable you to:

Eliminate the need for cold chain storage
Extend shelf life at ambient temperature
Enable single assay protocols

However, the most suitable route will depend on the composition of your formulation.

Lyophilising removes more water and is much more controlled and predictable, so you can experiment with conditions to achieve the optimum end product for your application. However, lyophilising requires additional, specialist expertise and equipment.

If you’re not sure which process is best for your formulation, be sure to read our blog on benefits of lyophilising (freeze drying) and air drying.

How do lyo beads improve on the traditional lyophilisation process?

Lyo beads can increase assay accuracy and speed to result. They’re significantly more cost-effective to manufacture than assays that are lyophilised in traditional formats, particularly for Point of Care testing.

Beads provide a perfect solution for lyophilising reagents for use in Point of Care platforms. A single, accurate dose of the reagent is lyophilised in a durable sphere. This can then be sub-assembled into cartridges later in the manufacturing process.

This provides a far more efficient and cost-effective use of freeze-drying capacity, resulting in a throughput uplift of up to 1,000 times the volumes achieved by lyophilising in situ.

Lyophilised beads can also have a longer shelf life than cakes lyophilised in vials, provided they are stored correctly.

Like all lyophilised reagents, beads can absorb moisture quickly when they are exposed to ambient air. However, as beads are reconstituted individually, exposure time for each bead can be minimised.

There is no central stock, so all the other beads remain sealed – preserving their shelf life and reducing wastage.

Why are lyo beads so beneficial to Point of Care testing?

Lyophilised beads provide an effective solution for lyophilising reagents used in POCT systems.

A lyophilised bead is a single, accurate dosage of the reagent – lyophilised as a sphere. It can be sub-assembled into cartridges using various technologies, such as automated ‘pick and place’ systems, which dramatically increase manufacturing throughput and reduce the cost per unit.

Beads are optimised for stability, size and reconstitution properties. This results in a tailored solution specific to the cartridge architecture and fluidic requirements of a particular test.

Learn how lyophilised beads are revolutionising point of care testing.

How are lyo beads created?

Biofortuna has leveraged years of experience to create a sophisticated lyo bead manufacturing process. It guarantees a reliable and predictable output without snags, delays, or the potential for expensive rework.

This process centres around four key processes:

Formulation optimisation, where the ideal freeze-drying conditions of the assay are established before the lyophilisation process begins. This involves pinpointing the exact temperature where a formulation will collapse, in order to create the optimal conditions required for manufacture.
Automated dispensing, where accurately measured droplets of the formulation are dispensed into liquid nitrogen. This accuracy will ensure that each lyo bead creates a precision dose for its final application.
Lyophilisation, where the usual primary and secondary drying cycles take place.
Quality control, where the formulation is tested to meet the required standards for appearance, size and dry weight.

You can find the full details of this process here.

See Biofortuna's manufacturing process in this infographic

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See Biofortuna's manufacturing process in this infographic