Operations strategy for a scalable CGT supply chain: key CXO insights

The cell and gene therapy (CGT) sector is rapidly evolving, with many early-stage companies developing innovative therapies for rare and serious diseases, particularly those preparing for commercial readiness. A robust and scalable supply chain is essential for successfully filing Biological License Applications (BLA) and launching CGT products on time. This article examines the unique complexities of CGT supply chain operations and highlights the importance of early strategic planning to align manufacturing, technology, and talent resources. We propose a three-phased roadmap for establishing a commercially ready supply chain, focusing on foundational infrastructure, preparation for scale, and readiness for launch. Additionally, we identify key success factors that are essential for building a resilient supply chain capable of supporting high-volume clinical manufacturing. By strategically addressing these critical elements, organizations can successfully navigate the complexities of CGT, enhancing patient access to innovative therapies.