How lyophilised beads are revolutionising point of care testing

Point of Care Testing delivers the accuracy of laboratory testing without the wait

Speed is critical when diagnosing. Clinicians must treat or manage the issue quickly and effectively. This urgency is particularly vital in cases of viral infection.

Will the patient need to go to hospital and, if so, do they need to be treated in an isolation ward? Should clinicians be wearing additional PPE? Can the patient’s family visit them?

When the test requires laboratory analysis, the result could take days to come back. This delay puts the patient, and those around them, at risk.

However, significant advancements are being made…

 

POCT can give an accurate result within hours or minutes

POCT platforms are exceptionally quick and easy to use. Operators simply need to add the patient sample.

The POCT platform conducts all the sample processing and data analysis usually undertaken in the lab and provides a clear result, enabling clinicians to identify and initiate the appropriate management.

 

How does POCT work?

POCT platforms usually comprise of a sample analyser instrument, as well as a disposable test strip or cartridge.

The cartridge contains all the chemical assay reagents needed to perform the test. These are stabilised in a format designed to maintain the functional performance of the test throughout its shelf life.

A stabilised Point of Care test could be stored, on average, for around 12 months, making it easy for NHS trusts to purchase in bulk and practical to use in surgeries, walk-in centres and chemists. Shelf life can be even longer depending on application and stabilisation method.

Many assay reagents, particularly molecular and enzymatic reagents used in POCT systems present a challenge to stabilise. Lyophilisation (freeze-drying) is often used to achieve the stability required.

During freeze drying, most of the water in the reagents is removed by sublimation and desorption at low temperatures and pressures.

This reduced water content results in reagents that are less reactive, and thus more stable.

In the manufacturing of POCT devices, assay reagents are typically dispensed into a specific part of the test cartridge and lyophilised in-situ.

Freeze-drying procedures must be optimised for each individual reagent and their respective cartridge components. However, this process can often prove challenging.

Furthermore, cartridges occupy significant volume in the freeze dryer, resulting in reduced batch sizes – often by more than 95%. These inefficiencies lead to significant increases in cost, time and batch-to-batch variability across multiple production runs.

However, there is a solution to the challenges presented by traditional lyophilisation.

 

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.

Key benefits of Point of Care Testing with lyo beads

 

How are lyophilised beads manufactured?

Lyophilised beads are produced by submerging accurate, single-droplet volumes of reagent into liquid nitrogen. This freezes the droplet instantly.

The frozen beads are then transferred to a freeze dryer.

Automated pump-based instruments can produce beads at a rate of thousands per hour and hundreds of thousands per working day. They can also be lyophilised in batch sizes of more than 1,000 – greater than equivalent in-situ cartridge processes.

This makes beads particularly suitable for markets with high, continuous demand, or where tests are required with unpredictable urgency, to fight an emergent threat.

The entire process (viewable here) ensures that freeze-drying times are reduced significantly, making manufacturing processes much more efficient and cost-effective. The beads can even be coloured with an inert visible dye, to enable easy identification. This allows the beads to be supplied in a wide variety of packaging formats to suit individual needs.

See how Biofortuna make lyophilised beads here.

 

Why choose lyophilised beads?

Lyophilised beads are the future of lyophilisation for medical testing, with a host of benefits to ensure speed, accuracy and cost-efficiency of manufacture.

They are:

  • produced in precise doses per sphere, ready for application and eliminating the potential for pipetting errors and contamination
  • cost-saving through reduced wastage, due to less user errors, longer shelf life and less exposure to moisture
  • pre-packaged in a cassette ready for reconstitution in the POCT device, with results delivered quicker as lab analysis is not required
  • formulated for optimal size and reconstitution properties to suit cartridges of all designs
  • able to be colour coded for ease of identification
  • able to support up to a 1,000-fold increase in manufacturing capacity per batch (compared with lyophilisation in-situ)
  • able to significantly reduce manufacturing cycle times, enabling more batches per week
  • robust for ease of transport and bulk storage without the need for refrigeration
  • compatible with automation placement for cartridge assembly.

 

Why choose Biofortuna as your contract manufacturing partner?

Expertise, risk mitigation, flexibility and accelerated speed to market are the four key benefits you will gain from partnering with a contract manufacturer. They will help you get a faster return on your R&D investment. You will benefit from all this if you partner with Biofortuna.

Our support is tailored around your exact requirements and is defined by a problem-solving mentality. We listen to precisely what you need and find the solution to match.

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

As global experts in freeze drying, we support a range of formats including bespoke lyophilised reagent beads.

A combination of technical expertise, ISO 13485 and ISO 17025 accreditation, FDA registration and state-of-the-art facilities mean that product developers can rely on the highest scientific standards when bringing their product to market.
See Biofortuna's manufacturing process in this infographic
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