ready-to-use cells for use in a bioassay, sometimes derived from cell lines previously used in an existing assay and sometimes de novo for a new assay. Tese banks may be developed in-house or by a specialist organization. A quick search of the internet reveals that over the past 5 years or so,
an increasing number of companies offer services for the development of custom-built ready-to-use cell banks and there is increasing commercial availability of off-the-shelf ready-to-use cells for the assay of classes of biological molecules of therapeutic interest. Many of the latter are available in kit form and come provided with detailed protocols and all required reagents. Such kits offer laboratories the possibility of rapid investigation of potential products and potential bioassay methods without the need for lengthy and expensive investment in cell line development, culture infrastructure and assay methodology development.
Te extent to which ready-to-use cells are being adopted for bioassays was indicated in a survey held in September 2016 at the 9th Annual BEBPA European Bioassay Conference (Dubrovnik, Croatia) and in March 2017 at the 1st Annual BEBPA USA Bioassay Conference (CA, US). At the European meeting, of 79 responses, 28% stated that ready-to-use cells were used ‘whenever possible’ and 20% stated that they were ‘just implementing’ their use. At the US meeting, of 77 responses, 45% were using ready-to-use cells ‘whenever possible’ and 21% were ‘just implementing’ [4].
Bioassays have long been regarded as the most problematic of the analytical techniques used in the biopharmaceutical industry due to the susceptibility of the cell cultures, and hence, assay results, to many external factors, which are often difficult to identify and control. Moreover, significant resources are required for the infrastructure to maintain cell cultures and provide cell stocks of consistent quality in a timely fashion for the bioassays. With ready-to-use cells, both the problems of cell stock variability and costs of culture facilities can be significantly reduced and the current trend indicates that this technology will play an increasing role in bioassays in the biopharmaceutical industry.
References
1. Gazzano-Santoro H, Chan LG, Ballard MS, Young JC. Ready-to-use cryopreserved primary cells a novel solution for QC lot release potency assays. Bioprocess Int. 2(2), 28–39 (2014).
2. Lamerdin J, Daino-Laizure H, Saharia A, Charter NW. Accelerating biologic and biosimilar drug development: ready-to-use, cell- based assays for potency and lot release testing. Bioprocess Int. 14(1), 36–44 (2016).
3. Robinson CJ, Lamerdin J. Ready-to-Use Cells in Bioassays for Quality Control of Biopharmaceuticals. Bioanalysis Zone, www.
bioanalysis-zone.com/2017/05/19/ready-use-cells_spotlbioanalysis_of_biopharma/ (2017).
4. Little L, Robinson CJ. Use of DOE for Bioassay Development. BEBPA
https://bebpa.org/whitepapers/Use-of-DOE-for-Bioassay- Development.pdf (2018).
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