Development, Validation, and Application of a Fully Integrated Automation System for Screening and Selection of High Yielding Production Cell Lines

The process of screening and selecting cell lines for the production of biopharmaceuticals can be very labor intensive and may involve screening thousands of cells lines in order to select high yielding producers. We have developed an integrated automation system to increase efficiency and throughput for screening and selection during cell line development. The system was designed to automate three sequential assays: (i) high throughput ELISA to identify high producers; (ii) digital imaging of high producers, and (iii) selection and expansion of high producing cell lines. The modular design of the system was a key feature, as it permits the integration or removal of components to accommodate a variety of bioassays. This paper describes the post-installation validation of the functionality of the key components of the system. The results of a direct comparison of screening and selection of high producing cell lines using the automation system and standard manual process are presented.