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Utilizing whole genome sequencing (WGS) and proprietary bioinformatics tools, Selexis is able to assess monoclonality of its RCB through an unbiased approach that identifies and validates integration sites, assesses clonality using integration sites as markers and provide transgene sequence, copy number and integrity. Additionally, Selexis has assessed a method for assessing clonality, based on a FISH-DNA platform, by detecting the specific location of the integrated recombinant transgene at the chromosomal level. In the case that two or more FISH patterns are found in the MCB, either the cell line is nonclonal in origin or chromosomal rearrangement has occurred during propagation. This method allows for analysis of single cells to assess the homogeneity within the parental population.
For more than 20 years, Selexis has been at the forefront of helping the biopharmaceutical industry advance life-saving mAb therapeutics into the clinic and to the market.
At Selexis, we believe in the promise of newer biologics and have committed significant resources to ensure our SUREtechnology Platform™ can meet the new expression challenges that these difficult-to-express proteins present.
We are proud of the role that Selexis’ cell line technology is playing in helping to deliver on the promise of bispecifics, which is a rapidly expanding class of drugs showing impressive results in multiple clinical trials.
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