Sphere Fluidics in Lab Manager, June 2021

Featured Article in Lab Manager: Upstream Bioprocessing: Innovative Trends and Developments in Cell Line Development

In biopharmaceutical production, time to clinic is critical, and there is a growing need to optimize the development of new cell lines for production. Cell line development (CLD) is a crucial step in upstream processes for advancing a novel therapeutic to clinical trial. But the current classical approach for the generation of cell lines is complex, multi-stage, and time consuming. This process inefficiency is due to several factors.

Trying to find a high-quality cell line is akin to looking for the proverbial “needle in a haystack,” which involves screening many thousands of different cell lines. Additionally, to reduce the need for further process development, cell line screening must be predictive of performance in a bioreactor. Another critical consideration is regulatory compliance, as regulatory bodies—such as the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA)—require proof that the manufacturing cell lines are derived from a single cell. Classical CLD workflows often contain two rounds of single-cell cloning, resulting in a lengthy process exceeding six months.

Researchers must balance process optimization with high-quality requirements and regulatory compliance to achieve fast and efficient Investigational New Drug approval. This can be difficult, especially because the technique used for single-cell processing and dispensing can impact single-cell viability. These various techniques are discussed in the article.

Read our article in Lab Manager here: : https://www.labmanager.com/big-picture/bioprocessing-overview-and-trends/upstream-bioprocessing-innovative-trends-and-developments-in-cell-line-development-25966