Freeze-Drying Diagnostics for COVID-19: Formulation Development and Selecting a Lyophilizer
Although it is considered a relatively gentle drying process, there are still risks and pitfalls when applying lyophilization to biomolecular reagents in diagnostic tests, which are different from the freeze-drying of generic pharmaceuticals.
The reagents generally utilized in PCR and ELISA based diagnostic kits for diseases like COVID-19 usually to contain labile components, like antibodies that are used to test for a patient s response to the virus, which can be difficult to stabilize for commercial use, or enzymes that must be preserved for longevity in the supply chain.
Dr. Kevin Ward, Director of Research and Development at Biopharma Group, UK, recently gave a webinar looking at numerous aspects of formulation and cycle development in the lyophilization of diagnostic reagents. These aspects included those needed for COVID-19 testing, which may be different to regular diagnostics; this