The enhancements seen in diagnostic testing over the last 40 years have been nothing short of remarkable. In the UK alone the survival rate of cancer patients has doubled, and much of this is attributed to earlier and targeted treatment, facilitated by accurate, early diagnosis.
But for enhancements in diagnostic performance to deliver a step change in global health and wellbeing, speed of diagnosis and access to testing must continue to improve.
Point of Care testing is a major enabler for this. It is exceptionally quick and simple to administer. The operator adds the patient sample to a cartridge containing a diagnostic assay and inserts it into the Point of Care platform. The device then conducts all the sample processing and data analysis previously undertaken in a laboratory, enabling clinicians to identify and initiate the appropriate treatment or management much sooner.
Developing a Clinical Point of Care assay
If you are planning to develop an assay for a Clinical Point of Care test, there are a number of key considerations that should be addressed at the design stage.
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Assay stabilization
One of the major limitations of Point of Care testing today is the availability and cost of specialist fridges and freezes required to keep diagnostic assays stable during transportation and storage.
This “cold – chain” process, where assays must be kept at an exact low temperature at all points from manufacture to use, adds substantial shipping and storage costs to the testing programme as well as increasing its carbon footprint.
A solution to this is to stabilise the assay at the point of manufacture using a technique such as Lyophilization. This involves removing the water from an assay to the point where it is no longer biologically or chemically active. The advantage of Lyophilization is that it allows assays to be transported and stored at ambient temperature with no loss in performance, making it much more practical to transport and store in community health settings.
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Cost per test
Large scale diagnostic testing needs to be affordable. Whatever method you choose to keep your assay stable, you will need to ensure it can be manufactured efficiently. If you opt to Lyophilize your reagents, doing so within the cartridge could be a limiting factor in terms of manufacturing batch size as the cartridges themselves will take up freeze dryer capacity.
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Cartridge design
Similarly, if you are designing an assay for a microfluidic cartridge, Lyophilizing your reagents within the device may damage the chips and sensors within it.
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Multiple reagents
Many microfluidic cartridges contain multiple reagents housed separately. These are added to the sample in a specific sequence controlled by the platform. If these reagents require different storage conditions, you may have little choice but to Lyophilize. Even if you do so, if the reagents also have different freeze-drying conditions this will have to be factored into the Lyophilization process.
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Speed of reconstitution
If you do Lyophilize your assay, you will need to consider the rate at which the reagents reconstitute, impacting the overall speed to result time.
Choosing the right Lyophilized format – Lyophilized beads
As you can see, whilst Lyophilizing your assay will make it far more practical and affordable to transport and store, there are still several challenges to overcome.
A relatively new option is to Lyophilize your reagents as beads.
Lyophilized beads are an accurate dose of single reagent or multiple reagents, freeze-dried as a robust sphere. They can be sub-assembled into cartridges using various technologies, such as automated ‘pick and place’ systems.
Lyophilizing your reagents as beads, and then sub-assembling them into the cartridge has several benefits:
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Increased batch capacity and reduction in the cost per test.
Lyophilizing reagents in the cartridge takes up space. Lyophilizing them as beads and then placing them in the cartridge can increase a single batch capacity by up to 1000x dramatically reducing the cost per test.
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Protects the cartridge
Sub-assembling the cartridges with Lyophilized beads also means your cartridge is not subject to the lyophilization process, eliminating the risk of damage associated with Lyophilizing in situ.
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Manufacturing flexibility – “Pick ‘n mix”
It is exceptionally difficult and time consuming to Lyophilize reagents with different freeze-drying conditions within the cartridge. Lyophilizing as beads allows you to customise the components and diagnostic applications of your assay.
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Faster speed to result
Lyophilized beads have a greater surface area than cakes and therefore reconstitute faster, delivering a faster speed to result.
How are lyophilized beads manufactured?
Lyophilized beads are produced by submerging accurate, single-droplet volumes of reagent or reagents 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.
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 makes Point of Care assay manufacturing much more efficient and cost-effective. The beads can even be coloured with an inert visible dye to enable easy identification. Beads can also be supplied in a wide variety of packaging formats to suit individual needs.
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 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 Lyophilization.
As global leaders in freeze drying technology, we support a range of formats including bespoke Lyophilized reagent beads.
A combination of technical expertise, ISO 13485 and ISO 17025 accreditation, FDA registration and state-of-the-art facilities mean that assay developers can rely on the highest scientific standards when bringing their product to market.
Like to know more? Our team would be delighted to have an informal exploratory discussion.
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