Open vs. Closed Aseptic Processing: Cost Savings and Regulatory Success

A Biomanufacturing Success Story: Closed Systems Optimize Operations

A leading biomanufacturer sought to enhance the sterility of their autologous and allogeneic therapeutics production. Genesis AEC partnered with them to address the challenges of expedited biological material transfers, gene manipulation, decontamination, and regulatory compliance.

Our initial assessment revealed a traditional manufacturing environment with manual processes within a Grade A BSC against a Grade B background. A rigorous analysis of their operations – encompassing apheresis, thaw/wash/incubation, sorting/sampling, expansion/harvest, and cryopreservation – identified the potential for a cost-effective transition to a Grade C cleanroom with integrated Grade A closed systems.

Risk Mitigation for Biomanufacturing

We 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

Our redesigned facility proposal emphasized Grade C or D suites with Grade A closed system isolators. This 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.)

Cost Analysis: Open vs. Closed Systems

While closed systems entail higher upfront equipment and validation expenses, the long-term cost benefits 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: A Compelling ROI

A 5-year ROI projection demonstrated substantial savings achieved 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

Despite upfront investment, closed systems offer financial rewards and operational excellence. Genesis AEC’s expertise in facility design and risk mitigation positions biomanufacturers for long-term success in this dynamic industry.

Contact Genesis AEC to learn how we can transform your biomanufacturing operations.

Photo: SKAN