Lessons from a COGS Analysis Workshop: Strategic Insights for ATMP Manufacturing

Why COGS Analysis Matters in ATMP Manufacturing

In the rapidly evolving world of Advanced Therapy Medicinal Products (ATMPs), the cost of goods sold (COGs) remains a critical barrier to commercial viability. This is largely due to the complexities of manufacturing. Estimates for the average COGs for a gene therapy alone are in the range of $500,000 to $1 million per dose. These therapies—ranging from cell and gene therapies to CAR-T treatments—are transformative but expensive to produce. To ensure broader patient access and long-term sustainability, COGs must be addressed early in the development lifecycle.

At the most recent ISPE Annual Meeting & Expo, Genesis hosted a pivotal workshop that brought together industry leaders to explore how COGS analysis can be integrated into early-phase facility and process design. This article summarizes the key findings and methodologies from that workshop, offering actionable insights for pharmaceutical engineers and facility planners.

🔗 Read the full article in Pharmaceutical Engineering (PDF)

Key Learnings from the COGS Analysis Workshop

1. Early-Phase Design Decisions Have Long-Term Cost Impacts

The workshop emphasized that decisions made during conceptual design—such as open vs. closed processing, cleanroom classifications, and equipment selection—can significantly influence long-term operational costs and patient affordability. These decisions affect:

• Facility capital investment
• Manufacturing efficiency
• Regulatory compliance
• Speed to market

2. Closed Systems Offer Strategic Advantages

Transitioning from open to closed systems using single-use technologies (SUTs) and isolators can reduce contamination risks, lower HVAC costs, and streamline operations. However, this shift requires upfront investment and process development, especially for autologous therapies like CAR-T.

3. Real-World Case Studies Demonstrate COGS Modeling in Action

Three anonymized case studies were analyzed:

• Case 1: A startup scaling from 60 to 1,000 patients using open and closed BSC-based processes.
• Case 2: A biopharma company transitioning from 300 to 4,000 patients, evaluating 2D culture vs. bioreactor-based closed systems.
• Case 3: A CAR-T developer scaling from 54 to 2,000 patients, facing complex process development for closed systems.

Each case illustrated how COGs modeling tools can guide strategic decisions in facility layout, staffing, and equipment planning.

4. Tools and Methodologies for COGS Analysis

The workshop used a simplified Excel-based COGS model that included:

• Personnel costs (manufacturing, compliance, support)
• Facility costs (HVAC, environmental monitoring, depreciation)
• Direct materials (consumables, reagents, packaging)
• Equipment depreciation and service costs

This model enabled sensitivity analysis and scenario comparisons, helping teams identify cost-saving opportunities and operational risks.

Strategic Takeaways for Pharma Engineers

• Integrate COGS analysis early in facility and process design to avoid costly retrofits and inefficiencies.
• Use data-driven tools to model different production scenarios and assess cost impacts.
• Prioritize flexibility and scalability in facility design to accommodate future growth and regulatory changes.
• Collaborate cross-functionally—from process engineers to finance teams—to ensure holistic decision-making.

Related Resources from Genesis AEC

To further explore how COGS analysis and facility design intersect in ATMP manufacturing, check out these expert resources from Genesis AEC:

• 🔗 Reducing COGs in Cell Therapy Manufacturing
  A deep dive into how early-phase design decisions impact long-term cost efficiency in cell therapy production.
• 🔗 Key Considerations for Cell and Gene Therapy Manufacturing Facilities
  Explore best practices for designing flexible, compliant, and scalable ATMP facilities.
• 🔗 Genesis AEC: Pharma & Biotech Facility Design Services
  Learn how Genesis AEC supports life sciences companies with integrated design, engineering, and construction solutions.

Need Help with COGS Optimization or Facility Planning?

Genesis AEC specializes in helping life sciences companies design and optimize manufacturing facilities for ATMPs, biologics, and advanced therapies. Whether you’re scaling up from clinical trials or planning a commercial launch, our experts can help you reduce costs, improve efficiency, and accelerate time to market.

👉 Contact us for a complimentary consultation and discover how we can support your next project.