Bioprocessing App Note

Automated Evidence of Clonality

As medicine advances to become more specialized to an individual’s needs, processes to develop these therapies need to be refined to ensure safety for patients. One such critical aspect of these therapies is proof of monoclonality. Across the globe, regulators require documented proof that a master cell bank has derived from a single cell, which provides consistency in the manufacture and scale-up of these therapies. This requirement is regularly a bottleneck in the cell line development workflow, leading to longer and more labor-intensive processes.

The conventional methods of image analysis typically involve whole well imaging of a single cell, followed by a timeconsuming manual inspection. Depending on the quality and clarity of the images, cells within a microplate can be difficult to find and distinguish from debris and image artifacts. Often, this raises concerns around subjectivity and inaccurate classification. Single cells can be especially difficult to identify due to their small size in relation to the well area, and their mobility around the well.

Advanced Instruments has developed the next generation in cell line development imaging technology with the Cell Metric® X. The Cell Metric X provides an innovative, artificial intelligence driven network that automatically detects a single cell within a microplate. The network has been meticulously designed to distinguish between single cells, aggregates and debris, thereby saving weeks of time and labor and reducing user bias.

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