It’s no surprise that the need for molecular diagnostic assays is growing at an unprecedented rate.With new biomarkers being discovered and standard catalog reagents becoming more accessible, diagnostic developers and manufacturers can create molecular tests faster than ever before.

Still, there are challenges to overcome. Standard catalog reagents, most commonly formulated with glycerol and other additives for stability in wet chemistry format, require cold-chain handling and storage.

We also highlight the importance of working with a partner from the beginning of your development process through to commercialization to ensure that diagnostic tests are reliable and efficient for accurate patient diagnoses.

Lyophilization: A Promising Solution

Lyophilization is a process where enzymes or reagents are freeze-dried into solid, stable particles.

This process is widely used to preserve a variety of materials, including food, pharmaceuticals, and biological samples. A major advantage in molecular diagnostic applications is that the enzymes can be lyophilized, and in many cases, in combination with the necessary buffer components and/or oligonucleotides (e.g., primers and probes) necessary to run the test, thereby completely eliminating any mixing or handling steps at the point-of-use. Samples and their associated target nucleic acids can simply be used to rehydrate the freeze-dried reagents and the test is ready to run.

The Many Benefits of Lyophilization

Unlike wet reagents, lyophilized products are solid and stable until resuspended. This provides a solution that addresses some of the challenges seen in molecular diagnostics.

The stability of lyophilized products translates to increased shelf life at ambient conditions and cost savings as diagnostic manufacturers and laboratories no longer have to pay for cold chain handling, shipping, delivery, and freezer space.

Lyophilization May Help Make Point-of-Care Diagnostics More Accessible

The COVID-19 pandemic has strained the infrastructure for manufacturing and delivering molecular diagnostics around the globe. Material shortages, limited amount of testing facilities,lengthy times to provide results to patients, and both cost and logistics associated with rapid testing scale-up all pose challenges to the success of established clinical diagnostic methods for detecting viral infections.

To alleviate these challenges, diagnostic tests need to be easier to use and inexpensive to send to any type of location.

This is where lyophilization can play a major role.

Key Considerations for Successful Lyophilization

There is no magical “one size fits all” approach for creating a reliable and robust lyophilized assay for aparticular application. You need knowledge and expertise at every step.

For successful lyophilization, it’s critical to have an understanding of the biology and chemistry of the reagents, the physics underlying the process, and how these can impact assay performance.

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