Why vaccine scale-ups fail: the hidden role of tech transfer, quality systems, and organizational readiness
Vaccine Insights 2026; 5(8), 417–437
10.18609/vac.2026.053
Vaccine scale-up failures are rarely caused by a single technical error. They emerge from the simultaneous failure of four interdependent domains: process design and physical scale-up, technology and knowledge transfer, analytical and quality-system readiness, and organizational and workforce readiness. This review examines why manufacturers fail to bridge the gap between laboratory success and commercial-scale production, drawing on historical cases that illustrate distinct facets of this problem, including the Cutter Incident (1955), the Chiron Liverpool contamination (2004), and the Emergent BioSolutions collapse (2021). It identifies systemic failure patterns across traditional and next-generation vaccine platforms, explores tacit knowledge transfer, analytical readiness, and workforce competency, and outlines what good-practice scale-up looks like. A nine-gate technology transfer framework is proposed, informed by World Health Organization (WHO) Technical Report Series (TRS) 1044 and International Council for Harmonisation (ICH) guidance, before a forward look at distributed manufacturing, artificial intelligence (AI)-assisted monitoring, and continuous production aligned with ICH Q13.