An industry perspective approach and control strategy for implementation of ready-to-use cells in bioassays: survey outcome and recommendations

The BioPhorum Development Group is an industry collaboration enabling the sharing of common practices for the development of biopharmaceuticals. Bioassays are an important part of an analytical control system. Utilization of ready-to-use cells can increase operational flexibility and improve efficiency by providing frozen cell banks uniform stock while removing challenges associated with maintaining cultured cells. The BioPhorum Development Group-Bioassay workstream conducted an intercompany benchmarking survey and group discussions around the use of ready-to-use cells for bioassays. The results of the collaboration provide alignment on nomenclature, production, qualification and implementation of ready-to-use cells to support the assay life cycle. Draft questions were composed by the authors based on prior knowledge of the issues associated with ready-to-use cell use. Questions were further refined through open discussion among the authors. Respondents answered the questions in a blinded fashion using Microsoft forms. One author compiled the results for open discussion among the BioPhorum members.