Ensuring that biotherapeutics are derived from a single clonal source has been stipulated by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) in order to ensure consistency and quality of production and to reduce population heterogeneity. Aligned with these requirements, the Cyto-Mine® Single Cell Analysis System has been specifically designed to ensure monoclonality via accurate and reliable single cell dispensing.
To demonstrate the suitability of Cyto-Mine® as a tool for cloning cells, we conducted a study to examine the fidelity of Cyto-Mine's advanced microfluidic dispensing technology.
Download the application note to learn how Cyto-Mine’s streamlined workflow offers :
- single cell visualisation providing evidence of monoclonality to support regulatory requirements.
- very high dispensing fidelity observed at ≥ 98.9% accuracy.