Method for determining cell clonality

The invention relates to a method for determining the clonality of a master cell bank (MCB) in which a transgene has been inserted. The method involves a combination of sequencing methodology and bioinformatic analysis, performed on multiple subclones originating from a common MCB, to establish a reliable set of reference transgene insertion regions in one reference subclone, and corresponding sets of comparative transgene insertion regions in one or more other subclones originating from the same MCB. Based on the degree of congruity between reference and comparative transgene insertion regions, the MCB is determined to be either monoclonal or polyclonal. 本发明涉及种确定其中已经插入转基因的主细胞库(MCB)的克隆形成能力的方法。该方法包括测序方法和生物信息学分析的组合，其在源自共同MCB的多个亚克隆上执行，从而在个参考亚克隆中建立可靠的组参考转基因插入区域并在源自相同MCB的个或多个其他亚克隆中建立相应的多组对比性转基因插入区域。基于参考和对比性转基因插入区域之间的致程度，确定MCB为单克隆或多克隆。