Hua Bi, Wenxiu Hou, Youxue Ding, Haohang Sun, Zhihao Fu, Xinchang Shi, Wei Jiang, Zengmin Du, Dening Pei, Xiang Li, Xi Qin, Chenggang Liang
• Prepared a single-stranded rAAV genome copy number reference material (GNR). • rAAV GNR has intact genome, consistent ITR/GOI titers, and is stable at ≤ -60°C. • Established a sensitive, reproducible dPCR titer system. • 11 enterprises and 1 institute completed multi-center copy number calibration. • GNR & dPCR system: vital for gene therapy QC, dosage norms, up industry standards.