What are lyophilised reagent beads?
Lyophilised reagent beads are durable spheres of freeze-dried material formed from accurately measured dispense volumes of customisable formulation.
These single-dose beads – like lyophilised cakes – retain long-term stability at ambient temperature and therefore do not need expensive cold chain shipping or refrigeration during storage.
This significantly increases the accessibility of diagnostic testing for difficult-to-reach patients, facilitating regular, near-patient testing in the community.
Lyophilised beads also present further performance and efficiency opportunities, particularly in terms of assay accuracy and speed and ease of process.
To bead or not to bead?
10 good examples of how ambient-stable lyophilised beads deliver performance, efficiency and cost benefits over traditional lyophilised formats:
- Lyophilised beads deliver greater assay accuracy – the dose consistency of beads minimises the potential for variance.
- Lyo beads are easier to handle – each all-in-one bead is pre-packaged and ready to use.
- Beads are faster – they maximise volume-to-surface-area ratio, giving you faster reconstitution and results.
- Beads have a much lower contamination risk because there is no central stock to corrupt.
- Beads typically have a longer shelf life than traditional cakes because each dose is reconstituted individually.
- Lyophilised beads reduce the set-up time needed for assays.
- Beads do not need pipetting – reducing the risk of errors (saving reagents, samples and time).
- Lyo beads do not need aliquoting or freeze-thaw cycles after reconstitution – giving you more consistent results and superior protection against sample/product degradation.
- Quality control is quicker, easier and more cost-effective with beads.
- Lyophilised beads offer a much more efficient route to large-scale manufacture for Point of Care Testing (POCT) devices.
Do lyophilised beads have a longer shelf life than traditional cakes?
Lyophilised beads can 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.
The reasons above are why lyo beads are helping revolutionise Point of Care Testing.
Selecting the right lyophilised beads partner
A good lyophilised bead manufacturer will help you turn life-changing concepts into reality.
Advanced lyophilisation expertise can overcome your freeze-drying stabilisation issues and accelerate your projects to the next level – overcoming barriers to scaling up. They can also help you to avoid expensive mistakes.
Here are seven questions you should ask when choosing a lyophilised bead contract manufacturer:
- Do they provide turnkey solutions that meet all your specific requirements for bead development and production?
- Are they ISO 13485 and ISO 17025 certified and FDA accredited? Some suppliers cite one or two accreditations – but does your preferred supplier have all three?
- Do they provide rapid proof-of-concept prototypes to help you be first to market, or meet challenges from competitors and allow you to close that gap?
- How fast can they run tests on experimental batches for evaluation before trials and production?
- How quickly can they turn around development projects?
- Can they handle cold chain and dry ice incoming shipments of reagents?
- How are the lyo beads sealed? Are special packaging options available?
Assay developers outsource their projects to Biofortuna as a trusted partner for custom development, contract manufacturing and genomic services. We can develop PCR assays in lyophilised, air-dried and liquid formats, using a range of different technologies.
Biofortuna supports diagnostic product and platform developers, research groups and not-for-profit organisations. We provide custom services and turnkey solutions.
Working with a knowledgeable and experienced lyophilisation partner can:
- accelerate formulation development
- ensure a cost-effective lyophilisation or air-drying process
- support you through a regulatory approval process
- reduce the overall time and cost of bringing an assay to market or deploying an assay in the field.
Our support is tailored around your exact requirements and defined by a problem-solving culture. We listen to precisely what you need and tailor a solution to meet those needs.
A combination of technical expertise, ISO 13485 and ISO 17025 accreditation, FDA registration and state-of-the-art facilities mean that 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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