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Purpose <p>Many emerging economies possess strong biotechnology research capacity yet struggle to translate this capability into inspection-ready Good Manufacturing Practice (GMP) manufacturing and sustained biologics commercialization. Existing analyses often address infrastructure, workforce, regulation, or funding in isolation, without a systems framework explaining how these elements interact to shape commercialization outcomes. To address this gap, this study proposes an integrated ecosystem-level framework for evaluating biologics manufacturing readiness.</p> Methods <p>In this study, Failure Modes and Effects Analysis (FMEA) was adapted from a process-level quality tool to an ecosystem-level, multi-domain analytical framework spanning operational manufacturing readiness and governance–regulatory architecture. Failure modes were identified from pharmaceutical engineering guidance, quality risk-management standards, supply-chain resilience literature, and the author’s industrial experience in biologics process development and GMP manufacturing. Each parameter was scored for severity, probability, and detectability using a qualitative, expert-informed approach supported by literature and industry experience. Risk Priority Numbers (RPNs) were calculated, ranked, and analyzed using Pareto methods, and mitigation strategies were mapped directly to each failure mode.</p> Results <p>The analysis identified 23 ecosystem-level failure modes with RPNs ranging from 120 to 504. The highest risks clustered at critical transition points, including pilot-to-GMP continuity, GMP manufacturing capacity, workforce readiness, supply-chain resilience, strategy coherence, funding continuity, and early regulatory engagement. Pareto analysis showed that a limited subset of parameters accounts for most ecosystem risk, while mid- and lower-RPN factors represent latent vulnerabilities affecting scalability, inspection readiness, cost efficiency, and institutional learning. Operational and governance risks were tightly coupled as evidenced by comparable domain contributions and across-domain dependencies of high-RPN failure modes. This highlights the importance of coordinated system-level intervention rather than isolated technical improvements.</p> Conclusion <p>Ecosystem-level FMEA provides a transparent and transferable framework for prioritizing interventions and sequencing actions to enable sustainable biologics manufacturing in emerging economies. By extending FMEA beyond traditional process-level applications to an integrated ecosystem-level framework, this study offers a novel approach for analyzing commercialization risk across technical and institutional domains.</p>

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Ecosystem-Level Risk Assessment of Biological Manufacturing in Emerging Economies Using Failure Modes and Effects Analysis (FMEA)

  • 期刊论文

  • 发表日期：

    2026年6月15日

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  • Dogan Ornek

摘要

Purpose

Many emerging economies possess strong biotechnology research capacity yet struggle to translate this capability into inspection-ready Good Manufacturing Practice (GMP) manufacturing and sustained biologics commercialization. Existing analyses often address infrastructure, workforce, regulation, or funding in isolation, without a systems framework explaining how these elements interact to shape commercialization outcomes. To address this gap, this study proposes an integrated ecosystem-level framework for evaluating biologics manufacturing readiness.

Methods

In this study, Failure Modes and Effects Analysis (FMEA) was adapted from a process-level quality tool to an ecosystem-level, multi-domain analytical framework spanning operational manufacturing readiness and governance–regulatory architecture. Failure modes were identified from pharmaceutical engineering guidance, quality risk-management standards, supply-chain resilience literature, and the author’s industrial experience in biologics process development and GMP manufacturing. Each parameter was scored for severity, probability, and detectability using a qualitative, expert-informed approach supported by literature and industry experience. Risk Priority Numbers (RPNs) were calculated, ranked, and analyzed using Pareto methods, and mitigation strategies were mapped directly to each failure mode.

Results

The analysis identified 23 ecosystem-level failure modes with RPNs ranging from 120 to 504. The highest risks clustered at critical transition points, including pilot-to-GMP continuity, GMP manufacturing capacity, workforce readiness, supply-chain resilience, strategy coherence, funding continuity, and early regulatory engagement. Pareto analysis showed that a limited subset of parameters accounts for most ecosystem risk, while mid- and lower-RPN factors represent latent vulnerabilities affecting scalability, inspection readiness, cost efficiency, and institutional learning. Operational and governance risks were tightly coupled as evidenced by comparable domain contributions and across-domain dependencies of high-RPN failure modes. This highlights the importance of coordinated system-level intervention rather than isolated technical improvements.

Conclusion

Ecosystem-level FMEA provides a transparent and transferable framework for prioritizing interventions and sequencing actions to enable sustainable biologics manufacturing in emerging economies. By extending FMEA beyond traditional process-level applications to an integrated ecosystem-level framework, this study offers a novel approach for analyzing commercialization risk across technical and institutional domains.