Abstract: 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.

Abstract: Provides herein is a method for identifying the specific cell lineage of cells in culture comprising the steps of determining from the nucleic acid molecules isolated from said recombinant cells in culture the presence of polymorphisms or SNPs at at least 5 different positions within at least five genes contained in said nucleic acid molecules, obtaining a genetic profile from the determination of the previous step, and identiyfing the cell lineage of said cells in culture from said genetic profile, and wherein the recombinant cells produce a recombinant protein.

Abstract: 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.