Clone selection is the process of identifying and isolating a single-cell derived colony — or clone — from a heterogeneous transfected cell population that demonstrates optimal productivity, product quality, and genetic stability for biopharmaceutical manufacturing. It is a critical step in cell line development and involves high-throughput screening methods such as fluorescence-activated cell sorting (FACS), limiting dilution, or automated single-cell cloning, followed by monoclonality assessment in compliance with ICH Q5D and regulatory expectations.
