Confident Clonality: How To Make Your IND Approval A Reality

A clonally derived Master Cell Bank is seen as a critical component of a robust, consistent process that ensures drug product quality and safety, and insufficient evidence of clonality in an IND submission can lead to costly delays when trying to get to first-in-human trials. In short, monoclonality assurance can make or break your IND application.

The Opto™ Cell Line Development workflow on the Beacon® system has been demonstrated to provide >99% probability of clonality from a single automated round of cloning. So just how exactly do we achieve this level of clonality assurance? The Opto CLD workflow tackles it in 3 parts.