Imagine you’re developing a new diagnostic test for a deadly virus that spreads rapidly. The test requires reagents for polymerase chain reaction (PCR), which amplify small quantities of DNA into a detectable amount. However, traditional methods of producing these reagents aren’t suitable for the scale required to produce the diagnostic tests on a mass level, and the reagents cannot be stored at room temperature.

This presents a significant challenge for the production and distribution of the diagnostic tests, as well as their shelf life. Fortunately, advancements in lyophilization techniques have made it possible to produce PCR reagents in a scalable and efficient manner.

How Lyophilization Enables PCR Applications

Lyophilization is a process that removes water from a substance by freezing it and then sublimating the ice—simply put, freeze drying. This enables materials to be kept in a well-preserved and shelf-stable form.

Lyophilization has revolutionized the storage of reagents used in PCR and point-of-care testing (POCT) devices. The benefits of lyophilization are significant as it enables the storage, utilization, and transportation of the material without the need for freezers, simplifying the entire process.

Lyophilization is also available in different forms, including lyobeads/microspheres, powder, and disc. The different forms of lyophilized reagents significantly impact the ease of dispensation, device complexity, scalability, ease of reagent onboarding, and overall yield.

Why Lyobeads Fall Short in Manufacturing

Lyobeads are commonly used for lyophilizing PCR reagents, but they do have limitations in manufacturing. Lyobeads are breakable and can escape reagent onboarding via static electricity. The handling of lyobeads can cause manufacturing bottlenecks that prevent efficient high yields. Lyobeads are not automation or robot-friendly and require expensive equipment investment.

Recipe restrictions come into play due to the above limitations, requiring minimum mass or more “sugar coating” with excipients to prevent breaking.

Furthermore, consistent lyophilization of reagents is challenging: it increases prices and reduces yield and efficiency. Finally, agitation is required during rehydration for reagent usage in order to prevent air bubbles from interfering with reaction or detection.

The Plastic Mesh Pod: Improving Speed-to-Market and Scalability in Mass Production

The plastic mesh pod is a new and innovative solution to the limitations of lyobeads for lyophilizing reagents used in PCR applications. Lyobeads are breakable, prone to manufacturing bottlenecks, and not automation friendly. On the other hand, plastic mesh pods offer several benefits, including:

Efficient Handling

Plastic mesh pods offer an easy and efficient handling solution for lyophilized reagents used in PCR applications. The pod is made from bio-compatible plastic material with a unique mesh bottom that allows for the easy handling, storage, and dispensation of reagents. Unlike lyobeads, which can escape reagent onboarding via static electricity, lyophilized reagents encased in plastic mesh pods can be easily assembled to PCR cartridges or microfluidic devices. This ease in reagent onboarding reduces waste from lost or broken reagents and improves overall production yield.

Scalability in Mass Production

The plastic mesh pod is designed for scalability in mass production. The pod enables higher production yields from robot automation without the need for expensive equipment specialized in handling lyobeads. The plastic mesh pod alleviates the errors associated with bead lyophilization and the need for liquid nitrogen, trays, and recipe restrictions. Lyophilized reagents in the plastic pod make production ramp up faster than lyobeads, as assembly automation of plastic pods are less complex and less costly than automating control of lyobeads.

Improved Speed-to-Market

The plastic mesh pod is an excellent solution for improving speed-to-market in PCR applications. The pod is designed to reduce the complexities associated with the handling of  lyobeads in PCR applications. The protective plastic pod eases excipient requirements, reducing time for recipe formulations. When dissolving the lyophilized reagents for use, the mesh at the bottom filters air bubbles that could otherwise interfere with detection. This shortens development time as it eliminates the need to build agitation mechanisms to remove air bubbles. By simplifying the lyophilization process and achieving a reliable reagent onboarding process, plastic mesh pods enable faster and more cost-effective product launch and production ramp up of novel PCR devices.

Conclusion

The plastic mesh pod is an innovative solution to the limitations of lyobeads for lyophilizing reagents used in PCR applications. The pod offers efficient handling, scalability in mass production, and improved speed to market, making it an excellent choice for product developers and manufacturers who want to improve PCR device production efficiency and yield.

For more information about plastic mesh pods and how they can benefit your project, contact Enplas today to speak with an engineer about your needs.