Top 5 Cell Line Development Challenges (And How To Avoid Them)

Cell line development (CLD) is a critical early step in biologics manufacturing, especially for complex or difficult-to-express molecules. However, many programs encounter recurring challenges that can derail timelines, inflate costs, and compromise product quality. This article outlines five common CLD pitfalls: unpredictable performance during scale-up, cell line instability, lack of experience with complex formats, inadequate analytics, and inefficient tech transfer. Each challenge is explored with practical guidance on what to look for in a partner, including platform capabilities, analytical infrastructure, and commercial experience. The piece emphasizes the importance of early manufacturability assessments, integrated development workflows, and specialized expertise in handling advanced therapeutics like multispecific antibodies and fusion proteins. With insights drawn from real-world experience and validated strategies, the article equips drug developers with the knowledge to identify red flags early and make informed decisions that support long-term success. For programs facing multiple CLD hurdles, the content encourages a proactive evaluation of current strategies and offers a framework for selecting partners who can deliver consistent, scalable, and regulatory-ready solutions.