Bringing A Culture Of Innovation To Cell Line Development

By Peggy Lio, Cytiva, and Miranda Kheradmand, Danaher Life Sciences

Recent innovations surrounding advanced therapeutic modalities have catalyzed a paradigm shift in the biopharmaceutical industry. Today, entire drug development pipelines may be dedicated to biologic drugs, and continued focus on data and technologies supporting development of novel biologics will likely serve to further streamline their development, validation, and scale up in the future.

Even among more advanced therapeutic modalities such as monoclonal antibodies (mAbs), a need for process standardization exists. Many cell line development (CLD) workflows used today are highly manual and repetitive. The complexity and importance of many CLD processing steps leaves little room for inconsistencies. These challenges, coupled with the industry’s increasing demand for greater output while maintaining constant budget and FTE workflows, has made accurate, comprehensive cell line characterization and cell culture screening a more critical consideration than ever.

More than ever, CLD is crucial to enabling successful process development and downstream scaling. In order to optimize and standardize the CLD workflows necessary to benefit downstream work, organizations must focus on technology and expertise needed to innovate in three key areas: automation, analytics, and digitalization. In doing so, operators can surmount or ameliorate challenges related to personnel turnover, resourcing, human error, turnaround times, redundancies, and data inconsistencies.