Case Study | Revolutionizing Pandemic Response Through Efficient mRNA Vaccines API ProductionLaunched a major mRNA Vaccines API program in Pandemic situation at a Pharma facility, leading to global supply on time and <22 days release

In the midst of the unprecedented global COVID-19 pandemic, OSICS NETWORK undertook a monumental challenge to address one of the most pressing needs of our time: the rapid and reliable production of mRNA vaccines.

This case study delves into how OSICS NETWORK, a renowned consulting firm specializing in corporate transformation and strategic management, orchestrated a game-changing initiative to ensure the timely supply of mRNA vaccines to the world, protecting the global population in a time of crisis.

SITUATION

The onset of the COVID-19 pandemic brought forth an urgent demand for mRNA vaccines to safeguard people worldwide. OSICS NETWORK was presented with the task of scaling up the manufacturing capabilities at a pharmaceutical facility from zero to producing one million vaccine doses per day within an astonishingly short timeframe of 60 days. This ambitious endeavor encompassed the activation of three distinct production lines, each capable of manufacturing three batches daily. However, the situation at hand was far from ideal, characterized by various challenges:

  • Chaotic Management: The pharmaceutical facility grappled with challenges such as supply shortages, inadequate staffing, unqualified production lines, a new facility lacking process stability and capability, and a high number of deviations, with 50 recorded for the first batch. Additionally, logistical and storage hurdles exacerbated the complexities.

  • Ineffective Project Management Office (PMO): The lack of a robust PMO structure hindered effective communication and decision-making among hundreds of stakeholders, including top management within the company.

APPROACH

In response to this formidable challenge, OSICS NETWORK adopted a comprehensive and methodical approach to instigate a transformative change:

  • Establishing a Strong PMO: OSICS NETWORK established a centralized Project Management Office (PMO) characterized by high cadence communication and streamlined decision-making processes. This structure enabled efficient coordination and decision-making among stakeholders.
  • Rigorous Risk Assessment and Mitigation: A comprehensive risk assessment was conducted, with daily monitoring of mitigation plans to proactively address potential issues.
  • Training and Staffing Strategy: A dedicated “WAR room” was established to oversee the training and staffing requirements, ensuring that the pharmaceutical facility was equipped with a competent workforce to meet production targets.
  • Strategic Ramp-up Plan: OSICS NETWORK developed a carefully planned ramp-up strategy, optimizing manufacturing processes to enhance efficiency and reduce operator dependency.
  • Release Taskforce and Continuous Monitoring: A release taskforce was implemented, monitoring operations on an hourly basis to ensure quality and adherence to schedules.
  • Change Control Governance: An effective change control governance framework was implemented, coupled with a facility qualification taskforce to maintain the integrity of the production process.
  • Expert Consultation: To bolster the efforts, OSICS NETWORK deployed five expert consultants full-time, providing invaluable support to a team of 150 FTEs responsible for the facility’s ramp-up.

IMPACT

The results of OSICS NETWORK’s strategic intervention were nothing short of remarkable:

  • Workforce Preparedness: Within just two months of engagement, 90% of the staff were trained and hired, demonstrating the effectiveness of the training and staffing strategy.
  • Production Milestone Achieved: The facility successfully reached its goal of producing one million vaccine doses per day, ensuring a consistent supply of mRNA vaccines.
  • Reduced Release Time: The average release time per batch was significantly reduced from 45 days to an impressive 22-25 days, enhancing the speed at which vaccines reached the global population.
  • Deviation Mitigation: The number of deviations, which initially stood at 50 for the first batch, was drastically reduced to an average of only 3 per batch after two months.
  • Effective Top Management Coordination: OSICS NETWORK’s intervention resulted in the active involvement and coordination of top management within the pharmaceutical company.

  • Enhanced Quality and Regulatory Approval: The implementation of lean processes effectively mitigated quality risks in critical areas, culminating in the regulatory approval of production lines for commercial pandemic launch.

In conclusion, OSICS NETWORK’s exemplary consulting expertise, strategic acumen, and relentless commitment to excellence played a pivotal role in transforming a tumultuous situation into a resounding success story.

Through their orchestrated efforts, they not only met the urgent demand for mRNA vaccines but also set a benchmark for efficient and agile response to global healthcare crises. OSICS NETWORK stands as a beacon of corporate transformation, shaping a better and more prepared future for our world.

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