How to select and optimize characterization criteria for assay-ready cells - A case study with iLite FGF21 cells

Characterization of cultured cell lines for production biologic material and cell lines used for potency applications are outlined in various guidance documents – but there is an absence of specific instructive information about the requirements for genetically modified cell lines, such as modified cell banks used for production of assay ready cells utilized for e.g. in bioassays, ADCC assays and neutralization assays in GxP applications.

Watch Karin Blume presentation on iLite

Karin Blume video image 2020

Here we offer examples from 10+ years working in development, validation and production of custom genetically modified cell lines and assay ready cells used in reporter gen assays. Examples will showcase critical aspects of characterization and include lessons learned as well as recommendations on what can be considered as an appropriate level for assay read cells.

Submit your contact details to get access to the presentation