Enabling Digital Innovation To Transform Cell Line Development

By Michael Barnes, IDBS, and Miranda Kheradmand, Danaher Life Sciences

The balancing act of ensuring the integrity and protection of a proprietary cell line development (CLD) process, data generated, and intellectual property (IP) while pursuing creation of a master cell bank is rife with challenges. While instruments and technologies supporting contemporary CLD workflows are more sophisticated than ever, they create more data points and analyze more parameters than can be feasibly processed by hand. The resulting wealth of data can, in turn, create new bottlenecks for a workflow. Securely housing and managing this increasing data output necessitates implementing strategies, software, and solutions that can support an interconnected, interoperable process capable of supplying the right data in the right format at the right time to inform decision-making.

Making the leap from incumbent systems ill-equipped to manage the diversity and breadth of data made possible by new analytical technologies can be incredibly challenging for legacy biopharmaceutical companies. Even those who have transitioned from analog notetaking to electronic systems may see very little benefit from the switch, as they may simply consider an ELN the new repository for any lab notes, and accessible only as a stand-alone piece of information. This lack of interoperability can hamper CLD activities between collaborating labs and can hurt later process development and scale-up activities. Combining these data siloes into a more integrated platform can greatly streamline and optimize a workflow by eliminating duplication of effort, creating efficiencies compounded by new approaches to analytics and automation, and improving data presentation and packaging to better conform to regulatory requirements.