An Industry Perspective Approach and Control Strategy for Implementation of Ready-to-Use Cells in Bioassays: Survey Outcome And Recommendations

Abstract

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.

Method summary

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.

Keywords: :

• bioassay
• biologicals
• cell-based assay
• development
• ready-to-use cells

Author contributions

All authors contributed equally to writing the survey questions, the discussions that led to the interpretation of responses and writing and reviewing the manuscript. In addition, JR White sought, analyzed and interpreted the data submitted for Figure 3.

Acknowledgments

The authors wish to acknowledge H-S Lam (GlaxoSmithKline), L Mackenzie (GlaxoSmithKline), L Bonnet (Fresenius Kabi SwissBioSim), A Viaud (Fresenius Kabi SwissBioSim) and T Milhiet (UCB) for ready-to-use and propagated cell data in Figure 3 and other members of the BioPhorum Development Group-Bioassay workstream for the useful discussions that contributed to this article.

Financial disclosure

The authors have no financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending or royalties.

Competing interests disclosure

The authors have no competing interests or relevant affiliations with any organization or entity with an interest in or conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending or royalties.

Writing disclosure

No writing assistance was utilized in the production of this manuscript.