At Creative Bioarray, we utilize Fluorescent In Situ Hybridization (FISH) for the genetic characterization of ST cell lines, offering insights into transgene integration sites and integrity. We have developed a method to evaluate clonality, leveraging a FISH-DNA platform for identifying the precise chromosomal location of the incorporated recombinant transgene. If all identified FISH patterns in the MCB are alike, it implies that the cell line has a clonal origin. Nevertheless, the observation of two or more distinct FISH patterns signifies that either the cell line does not originate clonally, or a chromosomal rearrangement has occurred during propagation.
This FISH method allows for analysis of single cells to assess the homogeneity within the parental population.
The requirements set by regulatory authorities for the monoclonality of cells in industrial production hold significant importance. This demand stems from the understanding that a single cell clone ensures uniform biological characteristics and consistent performance, fostering more predictable and reliable outputs. To ensure monoclonality, rigorous scrutiny during cell line development is essential. Any lapse in confirming monoclonality can potentially lead to variations in productivity and quality of the end products in industrial production. Hence, regulatory bodies emphasize stringent controls and comprehensive documentation to verify and ensure cell line monoclonality throughout industrial processes.
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