Case Study:

Scaling up drug substance production for Covid 19 vaccine

Challange

Global demand for the COVID-19 vaccine created immense pressure on manufacturing operations to rapidly scale production, with an initial target of approximately 800 million doses per year.

Achieving this required building a prioritized portfolio across Chemistry Manufacturing Controls (CMC), rapidly enhancing capabilities, strong cross-functional collaboration and embedding key elements of process excellence.

Our Approach

Commissioned to identify and lead Operational Excellence initiatives aimed at driving rapid improvements across manufacturing, operations, and facilities. We focused on:

  • Identified and aligned initiatives across functions to maximize throughput, improve material yield, and enhance production quality

  • Conducted workshops that uncovered over 40 improvement opportunities, which became projects. Projects were prioritized based on their impact on cycle times, yield, and quality

  • Developed standard processes, metrics dashboard and enabling tools to ensure consistency and efficiency

  • Established rigorous oversight with senior executives, supported by weekly and daily calls across work centers and project teams to monitor progress

Results

The cross-functional efforts paid off, achieving significant outcomes within six months:

  • 50% reduction in production cycle times

  • 10-15% improvement in material yield

  • 60-70% decrease in deviations per batch

Developing standard work processes and enabling tools were critical to achieving and sustaining portfolio objectives amidst the company's rapid growth.

By maintaining a daily focus on operational metrics and implementing standard work practices, we successfully met our targets, contributing to the organization’s critical mission during the pandemic.

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