Clone Documentation for regulatory

In recent years, regulators have indicated that assurance data provided by imagers should meet specific criteria and Solentim have automated this process, by way of generating the Clonality Report (see images below), to ensure no errors are made in the collation of this assurance data.

Clonality Report

The Clonality Report comes as standard on the Cell Metric and Cell Metric CLD

These reports, which can form part of the IND submission package, follow the valuable user-selected clonal wells from single cell to colony throughout the growth period with an image series (whole well and single cell image) in order to provide full time-and date-stamped data information for the well from single cell to colony.

Annotation is possible of the single cell and any other features e.g. debris. The reports are generated in minutes in PDF or PowerPoint presentation formats which can be exported and shared with interested parties e.g. cell banking groups, or a CMO customer.

Remote data viewer software enables the user to analyse data and generate clonality reports from their office computer.

The Clonality Report “meets the FDA requirements of whole well image and where single cell feature is located; allows highlighting of other features which can then be described away”
Dr Audrey Jia, Former FDA CMC
Reviewer. IBC Asia, Shanghai, May 2017

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