Industry approaches for implementation of ready to use ( RtU ) cells in bioassays

Bioassays are an important part of an overall CMC analytical control strategy and cell based assays are widely used for this purpose. Development of robust and reliable bioassays places increased requirements on the analytical cell banks with low lot to lot variability to deliver high quality potency data. Ready to use cells ( RtU ) offer many benefits including reduced assay variability and provides frozen bank of uniform cell stock for utilization directly in an assay.

To gain an understanding of current industry approaches for RtU cells, and to recommend the best practices for preparation, testing and control strategy for RtU cells, the BioPhorum Development Group Bioassay workstream conducted an intercompany collaboration exercise, which included a benchmarking survey and group discussions around approaches for reliably making RtU cells for bioassays. Selected results of this industry collaboration are presented on this poster to encourage discussion on com mon approaches to RtU cell manufacturing, testing and implementation across the industry.

The poster was presented at The BEBPA EUR Bioassay conference (September 2022) and CASSS Bioassay (August 2022). The results of the benchmarking survey can be seen in more detail by BioPhorum members here