Molecular diagnostic assay development and design is no simple task, and several factors affect the performance and usability of a test. Diagnostic companies can enhance assay stability and consistency, while reducing supply chain and shipping costs, by developing freeze-dried (lyophilized) assays. Because of these benefits, lyophilization can also enable accelerated entrance into global markets, as well as field use due to the ability to ship and store at ambient temperatures.

One major challenge in assay development and lyophilization is incompatibility with conventional enzyme formats. It is imperative that enzymes used do not contain glycerol in their buffers, as this interferes with the freeze-dry process. Lyo-ready enzymatic solutions must offer equal sensitivity, specificity, and reproducibility to ensure a robust assay.

Another hurdle in assay lyophilization is the development of an in-house freeze-dry process. In order to do this properly, companies must spend significant amounts of money on capital equipment, headcount, and infrastructure (humidity-controlled rooms, liquid nitrogen set-up, etc.). In this webinar we will discuss some of these challenges, as well as options for outsourcing lyophilization.

Learning Objectives: 

1. Discover the many apparent (and hidden) benefits of molecular diagnostic assay lyophilization, as well as important considerations in process development. 

2. Review how the challenges of assay lyophilization can be mitigated by incorporating enzymes with low glycerol content that still perform comparably to standard formats.

3. Summarize the important considerations in developing a freeze-dry process.