Closed System Cost Savings and Regulatory Success: View the Open vs. Closed Aseptic Processing System Analysis

A Biomanufacturing Success Story: Closed Systems Optimize Operations

A leading biomanufacturer sought to enhance the sterility of their autologous and allogeneic therapeutics production. Subsequently, Genesis AEC partnered with them to address the challenges of expedited biological material transfers, gene manipulation, decontamination, and regulatory compliance. So, through a comprehensive assessment, we determined they could garner a closed aseptic processing cost savings of more than $11 million in a 5-year timeline.

At first, our beginning evaluation revealed a conventional manufacturing setup relying on manual processes within a Grade A BSC, set against a Grade B background. However, a thorough analysis of their workflow – including apheresis, thawing/washing/incubation, sorting/sampling, expansion/harvesting, and cryopreservation – revealed an opportunity to cost-effectively transition to a Grade C cleanroom equipped with integrated Grade A closed systems.

Risk Mitigation for Biomanufacturing with Closed System

We initially developed a strategic risk mitigation plan centered on:

• Closing Primary Operations: Enhancing sterility and product safety.
• Environmental Classification Reduction: Cost savings through less demanding cleanroom requirements.
• HVAC Optimization: Right-sizing air handling for efficiency.
• Minimized Gowning Requirements: Streamlining operations, improving flexibility

Optimizing Biomanufacturing Facilities: Grade Reduction and Operational Efficiency

Subsequently, our proposed facility redesign prioritized Grade C or D suites with Grade A closed system isolators. Consequently, this approach offered significant advantages:

• Enhanced Operator and Patient Safety
• Reduced HVAC and Operational Costs (reduced classified spaces, fewer shutdowns, simplified waste management)
• Simplified Maintenance and Validation
• Higher Probability of Global Regulatory Approval (US FDA, EU EMA, etc.)

Closed System Cost Savings Can Be Significant

While closed systems entail higher upfront equipment and validation expenses, the long-term closed aseptic processing cost savings are compelling:

• ~1,000 SF Reduction in Classified Space
• ~5,000 SF Elimination of Grade B Space
• Removal of Multiple Grade B Airlocks
• 35% Air Handling System Downsizing
• $250,000 Savings in Facility Qualification
• $1.5 Million Reduction in Environmental Monitoring

Closed Systems: The Path to Regulatory Approval and Patient Safety

Financial Analysis: Closed System Cost Savings ROI

A 5-year ROI projection demonstrated substantial savings by switching to a closed system design, favorably impacting capital, equipment, facility, validation, and annual operating costs.

Key Takeaways

This case study proves that closed systems can transform biomanufacturing. Benefits include:

• Significantly lower facility and operational costs
• Streamlined environmental classifications
• Reduced operational complexity
• Enhanced regulatory compliance

Although closed systems require an initial investment, they deliver significant financial returns and optimize operational efficiency. Genesis AEC’s expertise in facility design and risk mitigation positions biomanufacturers for long-term success in this dynamic industry.

Contact us to learn how we can transform your biomanufacturing operations.

Photo: SKAN