Continuous manufacturing has been widely proposed as a transformative approach to vaccine production, offering higher productivity, reduced facility footprint, and improved supply resilience. While upstream intensification technologies such as perfusion and fixed‑bed bioreactors have matured, downstream purification and regulatory implementation remain major bottlenecks preventing widespread end‑to‑end continuous operation. This review synthesizes published research, industrial reviews, and vendor application knowledge to analyze technical bottlenecks across upstream and downstream vaccine manufacturing. Available continuous manufacturing technologies, including continuous cultivation strategies, single‑pass tangential flow filtration (SPTFF) and multi‑column chromatography, are discussed in the context of vaccine‑specific constraints. Finally, regulatory perspectives are examined, with emphasis on batch definition, validation, and lifecycle management in continuous vaccine manufacturing. The review highlights that successful implementation requires system‑level integration of process design, analytics, automation, and regulatory strategy.
Ravi Ganapathy (Thu,) studied this question.