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

John R. White, Sammina Ahmed, Jan Amstrup, Petra Bennington, Zhijie Jey Cheng, Peter Day, Keneshia K. Haenssen, Adi Kozminsky-Atias, Eva Martinez, Esther H.Q. Ong, Isam Qahwash, Elaine S.E. Stokes, Jenny Wang

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish
Pages (from-to)135-144
Number of pages10
JournalBioTechniques
Volume76
Issue number4
DOIs
StatePublished - 1 Jan 2024

Keywords

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

ASJC Scopus subject areas

  • Biotechnology
  • General Biochemistry, Genetics and Molecular Biology

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