Lyophilized beads are long-lasting spheroids, freeze-dried material formed from precisely measured, customizable formulations. Like all lyophilized formats, these single-dose beads maintain long-term stability at ambient temperature, so they do not require expensive cold chain shipping or refrigerated storage.
However, lyophilized beads also help to improve the accuracy of the analysis, as well as providing some efficiency benefits over traditional lyophilized formats.
Key Benefits of Lyophilized Beads:
Lyophilized reagent beads offer the following performance, efficiency and cost-effectiveness over traditional lyophilization formats:
Analytical precision: Lyophilized beads improve the accuracy of the assay because the single-dose consistency of the beads minimizes the possibility of variation.
Reduced risk of contamination: There is no central reserve to corrupt.
Increased speed to results: Bead-like structures are rebuilt faster due to their volume-to-surface area ratio.
Reduced risk of errors: Aliquote is not required after bead reconstruction, greatly reducing the risk of dosing errors.
Easy to operate: Each integrated head is pre-packaged and ready for use.
Reduced waste: Because each capsule contains a separate dose, there is no unnecessary reconstitution or exposure to any excess stock moisture.
Simpler quality control: Quality control is faster, easier, and more cost-effective for beads.
More efficient manufacturing: Lyophilized beads provide a more efficient path to mass production, especially for point-of-care equipment.
How lyophilized magnetic beads are revolutionizing point-of-care testing:
The process of manufacturing lyophilized (LYO) beads requires a high level of expertise and equipment. Working with a modern, experienced contract manufacturer will allow you to deliver the benefits of lyophilized beads without the high start-up costs, wasted trial-and-error testing, or risk.
FDM uses a very small amount of a complete recipe to freeze the sample and place the chamber under vacuum. These conditions are precisely controlled, reproducing the conditions under which the freeze dryer was manufactured. Observing the crystallization, freezing, and collapsing temperatures of a sample can help determine the optimal temperature, challenging reagents, and the effect of different concentrations of excipients on the final conditions.
DSC calculates the effect of glass transition temperature (tg') at different heating rates of the product. This provides an indication of the duration of the lyophilization cycle. This helps to calculate the possible benefits of sample annealing (heat treatment) to the final condition. Both FDM and DSC will be performed using a range of different formulations to identify challenging ingredients and the most promising excipient combinations at different concentrations. This allows customers to better understand the conditions for large-scale applications at the lowest cost of reagents.
Once the ideal assay freeze-drying conditions have been established, the precisely measured droplets of this formulation are dispensed into liquid nitrogen. This accuracy will ensure that each lyophilized bead contains the exact dose for the final application. (To be continued).