Building manufacturing efficiency in early process development: challenges and opportunities

Manufacturing efficiency is a major investment focus in the vaccine and biopharmaceutical industry, as reducing costs and improving scalability are critical for long-term success. While building robust upstream and downstream processes early can enhance long-term manufacturability, it may delay initial clinical entry, thus creating a strategic tension between speed to clinic and manufacturing efficiency. This article explores how emerging tools and approaches, such as artificial intelligence, automation, single-use systems, and standardized platform technologies, can help bridge this gap. Application of quality by design, which is a systematic, risk-based framework that integrates process understanding, critical quality attributes, and control strategies into early development, may serve as a key enabler in supporting more efficient tech transfer, flexible scale-up, and regulatory alignment. As regulatory agencies increasingly emphasize the early demonstration of process robustness, platform consistency, and lifecycle management planning, these integrated strategies may collectively provide a pathway to accelerate development without compromising long-term manufacturing success.

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