Turning cells into reagents: A proof-of-concept study comparing cultured vs. thaw-and-use cells in potency assays

CASSS Bioassays 2024 -- Potency represents a critical quality attribute for all drug molecules. Cell-based potency assays are designed and developed uniquely to reflect the mechanism of action of the drug molecule. Developing such assays is challenging, laborious and expensive and often has high assay failure rates. The use of cultured cells in these assays poses a number of challenges to assay development: Continuous culture is time consuming and expensive; cellular response varies with passage level and cell cycle stage; continuous culture causes a risk of contamination, which can lead to assay delays; and culture routines can lead to restrictions on assay scheduling. Many of these challenges can be overcome by switching to thaw-and-use cells.