Avoiding The Pitfalls: Five Lessons For Cell Therapy Manufacturing Success

By Joe Garrity, Executive Director, Head of Portfolio Management, Specialized Modalities

Clinical success is an important milestone, but it does not guarantee a smooth transition to commercial supply. In cell and gene therapy (CGT), delays in late-stage development often stem from gaps in chemistry, manufacturing, and controls (CMC) readiness. More than 70% of FDA Complete Response Letters cite quality or manufacturing deficiencies, underscoring the importance of addressing these challenges before a program reaches submission.

In this white paper, Joe Garrity, Executive Director of Portfolio Management, Specialized Modalities at Lonza, draws on more than a decade of experience in the CGT contract development and manufacturing organization (CDMO) sector to explore five recurring pitfalls that can hinder commercialization. These include selecting the right manufacturing partner, managing vein-to-vein logistics, initiating commercial planning at the appropriate stage, evaluating total cost rather than price alone, and preparing for automation and digital systems. For each challenge, Garrity outlines practical actions to help teams identify potential gaps and make informed decisions as development progresses. The discussion also examines why Phase 2 is increasingly viewed as a critical bridge between clinical development and commercial launch. Read the white paper to assess your program’s readiness, challenge key assumptions, and identify areas that may need attention before commercialization.