Biomedical Engineering and Bioengineering Commons^™

Proof That Can Travel - Documented Clonality Report For Regulatory Submission, Ian Taylor, Paul Miller

Cell Culture Engineering XV

Clonality is a key element of cell line development and is an important component of a regulatory submission. Indeed for BLA, the clonality of MCB is mandatory. Historically, the regulator has insisted upon 2 rounds of cloning for developing a cell line and assurance of monoclonality based on statistical outgrowth measurements. Recent improvements in high resolution whole well imaging of cells in microplates, enables the creation of indisputable image-based evidence for the growth of a colony from a single cell. This evidence eliminates a round of sub-cloning and results in several months of cell line development time being saved. However, …