Case Study

Vaccine Fill Line Operations

Source: CAI
GettyImages-1298781737 aseptic filling

This case study examines how a global life sciences organization achieved commercial vaccine production in under six months, reducing typical timelines by 40%. The initiative spanned three international sites, each equipped with high-speed vial filling lines and supported by harmonized CQV strategies. Key success factors included risk-based validation, digital integration through paperless systems, and proactive engagement with regulatory authorities.

These measures not only streamlined qualification activities but also improved equipment effectiveness by 25% and avoided $1–2 million in costs tied to delayed production. Lessons learned underscore the importance of early stakeholder alignment, agile project management, and knowledge transfer for multi-site deployments. Download the full case study to explore how operational readiness frameworks can transform large-scale, time-critical programs.

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