Selexis CHO Cells in Suspension-1

Clonality Assurance

Assessing 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 assess monoclonality of its RCB through an unbiased approach that identifies and validates integration sites, assesses clonality...

 

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 where all FISH patterns found in the MCB are identical, the cell line is clonal in origin. However, the presence of two or more different FISH patterns indicates that 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