By Yongho Ahn, Vice President, Head of CDO R&D at Samsung Biologics and John Gill, Director, Cell Line Development at Samsung Biologics
Cell line development represents a pivotal moment in a biologic’s broader developmental lifecycle. Optimal cell line development is crucial for successfully navigating clinical trials and diverse, challenging regulatory approval processes. To reduce time to market and keep costs low, many developers prioritize speed over strategy, risking expensive and disruptive redevelopment mandates.
To mitigate risk and deliver superior product quality, cell line developers should possess the deep technical expertise, sufficient resources, and long-term business strategy required to achieve value instead of bottlenecks. To realize this value, you should:
- Develop a top-quality cell line
- Align early development efforts to key IND and BLA parameters
- Stay flexible to control your time and costs
- Emphasize collaboration with specialist partners