Supplier Quality Reinvented: Managing High‑Risk Raw Materials and Global Supply Chain Instability in Cell & Gene Therapy

A rapidly increasing demand for cell and gene therapies, despite a stagnant increase in global manufacturing capacity, poses unprecedented challenges to the raw material sourcing and supply chain (RMSS) community. This article discusses the structural weaknesses of the RMSS of cell and gene therapies. These include limited capacity to produce viral vectors and plasmids, geographic concentration of the few specialist suppliers producing those raw materials, and patient-specific production in autologous therapies. Conventional approaches to supplier qualification may be insufficient for these high-risk biological materials, requiring a fundamentally different model for quality assurance. Potential approaches include deep dive technical assessments of prequalified suppliers, dual sourcing, and risk-based tiering of biological materials. Proactive supply chain risk management in clinical development involves the early consideration of the supply chain, planned instead of transactional partnership, geographic technology transfer capabilities, QMSs to manage supplier performance, advanced change control capabilities to account for biological variation, and rapid deviation management to shorten lead times. Regulatory agencies are increasingly requiring proof of supply chain resilience through documented risk management assessments that include justifications for sourcing decisions and contingency plans that are frequently used and exercised. Those organizations that recognize supplier quality management as a planned imperative and invest in dual-sourcing of critical raw materials, strong supply chains, and collaborative relationships with suppliers will deliver transformative therapies. In contrast, those relying on customary supplier practices risk supply failures and limiting patient access to breakthrough therapies.