The standard cell line development pathway at many contract service organizations is based solely on selecting clones by growth and productivity with little or no analytical characterization of the expressed protein. The use of protein analytics to support selection of clones that match desired product quality is important for second-generation processes and will be of utmost importance for biosimilar development. CMC Biologics performs sophisticated protein characterization using state-of-the-art analytical equipment combined with our robust cell line development platform to generate and identify production- quality clones with desired product quality attributes in very rapid timeframes.

Implementing protein analysis into the cell line development process requires a robust platform capable of producing consistent results and timeframes. More importantly, it requires flexibility to enable matching of specific product quality attributes in the midst of the ongoing clone selection process. CMC Biologics' CHEF1 expression platform is well suited to meet these stringent demands, as demonstrated in the following case study, wherein three separate antibody producing cell lines with specific glycan profiles were generated and identified in rapid timeframes.

Abstract

Background
The CloneSelect^TM Imager system is an image-based visualisation system for cell growth assessment. Traditionally cell proliferation is measured with the colorimetric MTT assay.

Results
Here we show that both the CloneSelect Imager and the MTT approach result in comparable EC50 values when assaying the cytotoxicity of cisplatin and oxaliplatin on various cell lines. However, the image-based technique was found non-invasive, considerably quicker and more accurate than the MTT assay.

Conclusions
This new image-based technique has the potential to replace the cumbersome MTT assay when fast, unbiased and high-throughput cytotoxicity assays are requested.