A Biomanufacturing Plan to Confront Future Biological Threats

The report advocates for a 'system of systems' approach to biomanufacturing in the US, integrating pathogen early warning, regulatory agility, and public-private partnerships to rapidly produce medical countermeasures (MCMs). It identifies critical gaps in supply chain resilience, workforce development, and business models, specifically noting a dangerous dependency on foreign sources like the People's Republic of China. The authors recommend that the US government de-risk private sector investment through sustained demand signals, establish 'pivot' contracts similar to the Civil Reserve Air Fleet, and create an interagency working group to coordinate biomanufacturing efforts across federal departments.

• Biomanufacturing can significantly reduce the timeline for developing and deploying medical countermeasures (MCMs)—including diagnostics, therapeutics, vaccines, and personal protective equipment (PPE)—by enabling a rapid and decentralized production model.
• The US faces critical supply chain vulnerabilities, with a Department of Defense investigation finding that 27% of essential medicines are at very high risk due to dependency on the People's Republic of China or unknown sources.
• A viable biomanufacturing business model requires government intervention to bridge the 'Valley of Death' between prototyping and full-scale production through financial incentives, loans, and sustained demand signals.
• The report proposes a 'pivot' model where the government establishes contracts with commercially viable biomanufacturing companies to maintain readiness, allowing them to switch to MCM production during emergencies in exchange for retainers or guaranteed business.
• To achieve a 'threat-agnostic' response capable of addressing unknown or genetically engineered pathogens, the US should invest in self-driving laboratories that utilize robotics and artificial intelligence to automate experiments and manufacturing.
• The report recommends a 'system of systems' approach that integrates pathogen early warning data with biomanufacturing pipelines and expedited FDA regulatory approvals to ensure MCMs are produced and distributed with maximum speed.
• Public trust is a major barrier to biomanufacturing success, exacerbated by misinformation, disinformation, and a lack of health literacy, particularly among historically disadvantaged populations.

APA

Green, S., Hillson, N. J., Moulton, J., Mukundan, H., Regan, D. P., & Tanjore, D. (2024). A Biomanufacturing Plan to Confront Future Biological Threats. The Council on Strategic Risks. https://councilonstrategicrisks.org/wp-content/uploads/2024/09/BiomanufacturingPlan-1.pdf

Chicago

Green, Shannon, Nathan J. Hillson, John Moulton, Harshini Mukundan, Daniel P. Regan, and Deepti Tanjore. A Biomanufacturing Plan to Confront Future Biological Threats. The Council on Strategic Risks, 2024. https://councilonstrategicrisks.org/wp-content/uploads/2024/09/BiomanufacturingPlan-1.pdf.

Wikipedia

{{cite report |last1=Green |first1=Shannon |last2=Hillson |first2=Nathan J. |last3=Moulton |first3=John |last4=Mukundan |first4=Harshini |last5=Regan |first5=Daniel P. |last6=Tanjore |first6=Deepti |title=A Biomanufacturing Plan to Confront Future Biological Threats |publisher=The Council on Strategic Risks |date=September 2024 |url=https://councilonstrategicrisks.org/wp-content/uploads/2024/09/BiomanufacturingPlan-1.pdf |access-date=23 October 2026 |via=Climate Insights Directory}}

BibTeX

@techreport{green2024biomanufacturing, author = {Green, Shannon and Hillson, Nathan J. and Moulton, John and Mukundan, Harshini and Regan, Daniel P. and Tanjore, Deepti}, title = {{A Biomanufacturing Plan to Confront Future Biological Threats}}, institution = {The Council on Strategic Risks}, year = {2024}, month = sep, url = {https://councilonstrategicrisks.org/wp-content/uploads/2024/09/BiomanufacturingPlan-1.pdf}, urldate = {2026-10-23}, note = {Indexed by Climate Insights Directory} }