Case Study: Full Clonality Assessment Of CHO Cell Line

Clonality assessment ensures that a biologic or cell/gene therapy product is derived from a single, genetically consistent cell. Without clear evidence that a master cell bank (MCB) originates from a single progenitor cell, manufacturers risk variability in product quality, inconsistent process performance, and regulatory scrutiny.

In this case study, a comprehensive genetic analysis was performed on a transgenic Chinese hamster ovary (CHO) master cell bank to characterize the bank and provide high-confidence evidence of clonality. Using Target Locus Amplification (TLA), Next-Generation Sequencing (NGS), and qPCR, the study assessed vector integrity, concatemerization, sequence and structural variants, integration sites, copy number, and breakpoint sequences for complete characterization of the MCB.