This Application Note explains how Cyto-Mine® enables rare cells to be mined from complex cell populations and subsequently cloned to microplates with proof of single-cell status via a seamless and fully automated process.

One of the most critical steps in submitting a New Drug Application (NDA) for a biologic is evidence supporting that the molecule is produced from a clonal cell line. Conventionally, this has relied heavily on presenting statistical probability that the cell bank was cloned from a single cell progenitor. More recently, cell-in well imagers have gained traction as a visual verification tool downstream of cloning by limiting dilution, cell sorting or colony picking. Download to continue reading…