Selexis CHO Cells in Suspension-1

Clonality Assurance

Establishing monoclonality of research cell banks (RCB) and manufacturing cell banks (MCB) is critical for successful and cost-effective biologic manufacturing campaigns and regulatory filings.

Selexis is able to establish monoclonality of its RCB through an unbiased approach that identifies and validates integration sites, establishes clonality...

 

Utilizing whole genome sequencing (WGS) and proprietary bioinformatics tools, Selexis is able to establish monoclonality of its RCB through an unbiased approach that identifies and validates integration sites, establishes clonality using integration sites as markers and provide transgene sequence, copy number and integrity. Additionally, Selexis has established a method for establishing 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.

Three Possible Solutions for Accurate Determination of Clonality of Cell Lines:

Selexis scenarios for monoclonality of CHO cell