Overcoming Cell Line Development Challenges Through Early-Stage Assessment And Management

By Seahee Kim and Daniel Buckley, Samsung Biologics

Cell line development (CLD) timelines, product quality, and drug stability continue to impose difficult bottlenecks, but those hurdles can be overcome through the early-stage development and application of high-throughput analytic methods. The data gleaned can be used to make informed decisions and to optimize resources, resulting in a more efficient and successful CLD process. Often, a CDMO partner is able to drive this effort forward, drawing from previous experiences.

Also, efforts to improve product quality and productivity often do not end with creation of the initial cell line. In fact, biopharmas increasingly want to replace their chosen cell line upon receiving IND approval and initial clinical results in order to maintain quality while improving titer. However, cell line replacement generally is more challenging than initial CLD because it can be time-consuming and requires more careful evaluation and planning.

Combined with an optimized process, Samsung Biologics’ DEVELOPICK platform can provide biopharmas with the opportunity to check their material’s development potential in a project’s early stages. The platform is a risk-mitigation tool that provides rapid analysis of molecules, which aids in identifying those molecules with the greatest chance of success.