By Dr Kevin Ward, Director of R&D, Biopharma Group
Lyophilization may be considered a relatively gentle drying process, but there are still risks and pitfalls when applying it to biomolecular reagents in diagnostic tests that are different to the freeze-drying of general pharmaceuticals.
Reagents typically used in ELISA and PCR based diagnostic kits for diseases, such as COVID-19 tend to contain labile components, such as enzymes that need preserving for longevity in the supply chain or antibodies to test for a patients response to the virus, which can be challenging to stabilize for commercial use.
Recently, Dr Kevin Ward, Director of Research and Development at Biopharma Group, UK presented a webinar exploring various aspects of formulation and cycle development in the lyophilization of diagnostic reagents, including those required for COVID-19 testing that may be different to regular diagnostics. This article summarizes the webinar and includes a selection of questions from the Q&A session.