Increase POCT Cartridge Yield with the Efficient Handling and Production of Lyophilized Reagents

Reliable plastic mesh pods to lyophilize, store, and dispense reagents

Problem

Lyophilization has proven to be invaluable to life science and biotechnology industries by enabling room-temperature storage of reagents used in point-of-care testing (POCT) devices. However, lyobeads are breakable and can escape reagent onboarding via static electricity. The difficulty involved in lyophilized reagent handling can cause manufacturing bottlenecks that prevent efficient high yields. Automated robotic arms or manual tweezers can easily miss, drop, or break the lyobeads. In addition, it’s difficult to consistently lyophilize reagents into lyobeads using liquid nitrogen or trays, a process which often requires manufacturers to reformulate reagent recipes (raising prices and reducing yield and efficiency). Finally, during dispensation, complex steps such as agitation are required to prevent the formation of air bubbles that can block reagent flow.

Solution

Lyophilizing reagents in a plastic meshed pod can improve the efficiency of the end product and increase the speed and scalability of mass production. The pod alleviates the errors associated with bead lyophilization and the need for liquid nitrogen, trays, and recipe restrictions. In addition, robotic arms or human hands can handle the lyophilized reagent better than traditional lyobeads, as they only need to grip the stable plastic pod and not the pellet itself. This helps to reduce losses via misses, breaks, or drops. As a result, automation and efficiency are improved for the diagnostic manufacturer, who will receive a higher production yield without the need for expensive equipment upgrades or time-consuming recipe reformulations. The addition of the mesh at the bottom of the plastic pod also filters air bubbles when dispensing, reducing the need for the added complexity of agitation for applications including NGS and PCR.

Problem

Lyophilization has proven to be invaluable to life science and biotechnology industries by enabling room-temperature storage of reagents used in point-of-care testing (POCT) devices. However, lyobeads are breakable and can escape reagent onboarding via static electricity. The difficulty involved in lyophilized reagent handling can cause manufacturing bottlenecks that prevent efficient high yields. Automated robotic arms or manual tweezers can easily miss, drop, or break the lyobeads. In addition, it’s difficult to consistently lyophilize reagents into lyobeads using liquid nitrogen or trays, a process which often requires manufacturers to reformulate reagent recipes (raising prices and reducing yield and efficiency). Finally, during dispensation, complex steps such as agitation are required to prevent the formation of air bubbles that can block reagent flow.

Solution

Lyophilizing reagents in a plastic meshed pod can improve the efficiency of the end product and increase the speed and scalability of mass production. The pod alleviates the errors associated with bead lyophilization and the need for liquid nitrogen, trays, and recipe restrictions. In addition, robotic arms or human hands can handle the lyophilized reagent better than traditional lyobeads, as they only need to grip the stable plastic pod and not the pellet itself. This helps to reduce losses via misses, breaks, or drops. As a result, automation and efficiency are improved for the diagnostic manufacturer, who will receive a higher production yield without the need for expensive equipment upgrades or time-consuming recipe reformulations. The addition of the mesh at the bottom of the plastic pod also filters air bubbles when dispensing, reducing the need for the added complexity of agitation for applications including NGS and PCR.

The Plastic Meshed Pod

The plastic meshed pod is a novel format that secures lyophilized reagents at room temperature in a stable geometry. The plastic is custom molded to fit the dimensions of any cartridge. The pod is equipped with a 30-micron mesh that A) holds the reagents in place using surface tension and B) filters air bubbles during dispensation. The reagents are lyophilized and safely stored in the pod during production and storage. Robotic arms can then automatically load the lyophilized plastic pods into diagnostic cartridges safely within nitrogen environments. In the hands of users, the lyophilized reagents can be easily dispensed via the mesh filter without added agitation to remove air bubbles. The simple and robust design of the mesh pod can be extended to other applications, including desalination and liquid chromatography.

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	Lyophilized Beads	Lyophilized Inside a Mesh Pod
Mass Production
Reagent Recipe	Lyobeads often have minimum mass requirements and need additional excipients to hold their shape during onboarding.	Fewer restrictions on minimum mass or excipients offer more freedom for chemists to formulate their own recipes.
Lyophilizing the reagent	It’s difficult to lyophilize beads in the exact volume repeatedly.	It’s easy to measure the same amount of lyophilized reagent and drop it into the pod.
Handling the lyophilized reagent	The beads require a low humidity environment (in a dry room of around 1% humidity) to remain lyophilized. The beads experience static electricity in low humidity. The spherical beads can roll around and are affected by static electricity, making handling more difficult.	The mesh pods require a low humidity environment to handle reagents in a pod. The mesh pods are not affected by static electricity in low humidity. Lyophilized reagents are securely contained in the pod and do not experience rolling issues.
Onboarding the lyophilized reagent onto cartridges	The lyobeads are difficult to accurately pick up with robot arms (that use vacuum pick-up methods) or tweezers by human hands and are easily breakable. This results in lower yield from missed, dropped, or broken beads. Handling improvements require costly equipment investments.	The robot arm or manual tool only touches the plastic pod and not the reagent directly. Also, the non-spherical geometry of the lyophilized pod makes it easy to be picked up and handled by fast-moving robots, with no worries of missing or breaking the lyophilized reagent.
Application Use
Dispensing the lyophilized reagent	Air pockets more easily form in beads that contain more sugar. These air bubbles block fluid channels for subsequent reactions, and agitation is essential for the dissolution of the reagent.	The mesh will automatically filter air bubbles, so agitation is not required, shortening the procedure for users.

Specifications

Shelf Life

More than one year when there are no liquid reagents in the same sealed cartridge.
Six months or more when the lyophilized reagents and liquid reagents are kept separate within the same sealed cartridge.

Recommended Materials

Polypropylene (PP)

Example Applications

Sample preparation
PCR
NGS
Other molecular diagnostics/testing
Liquid chromatography
Point-of-care testing (POCT)
Other in-vitro diagnostic (IVD) devices
Other testing and research

Pod Size and Lyo Reagent Volume:

This is customizable, depending on your assay design. For example, the pod size shown in the image to the right holds 150 µl of reagents.

Shorten Your POCT Development and Production Times

Enplas integrates your lyophilization and reagent onboarding needs into our automated plastic cartridge manufacturing processes. Contact us today to discover how.

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