The U.S. benefits greatly from a centralized capability to rapidly characterize preventive and therapeutic biologics to shorten release timelines, assure comparability across manufacturing sites, and improve stability assessment. These capabilities are critical for pandemic preparedness and national health security, reducing reliance on ad‑hoc methods and mitigating supply chain vulnerabilities for analytical reagents and reference materials.
ARP‑33 successfully established the Vaccine Analytics & Assays Center of Excellence (VACoE) testbed at NIIMBL HQ, fully equipped and validated with advanced analytical technologies (e.g., ELSD‑HPLC, light scattering particle sizing, capillary electrophoresis for mRNA fractionation, ELISA for mRNA concentration, TEM for structural analysis). The project delivered SOPs, centralized data infrastructure, and trained personnel, creating a national resource for government and industry to deploy standardized workflows for vaccine characterization and comparability assessments.
The project will enable unprecedented collaboration opportunities for vaccine innovators, SMMs and academics to converge on key techniques and fill gaps for making coronavirus vaccines more quickly and widely available to a broad US population.
The facility and equipment will be available for NIIMBL members to assess techniques and facilitate training and knowledge for implementation on a company-by-company basis that will positively impact the overall US preparedness and response to future pandemics.
This project enabled a national vaccine analytics testbed that improves characterization and release workflows for both manufacturers and suppliers, resulting in risk and cost reductions across development and commercial testing
Testbed Commissioning & Training: All equipment procured, installed, and qualified; vendor‑led training completed across HPLC (UV/fluorescence/ELSD), capillary electrophoresis, nanoparticle analysis, scattering, FTIR, fluorescence, UV, and microfluidic modulation spectroscopy, among others.
Method Readiness & SOPs: Developed and documented workflows for a comprehensive suite of analytical methods, including, ELSD‑HPLC, light‑scattering size analysis, capillary electrophoresis (mRNA fraction), ELISA (mRNA concentration), and TEM structural analysis, among others.
Data Infrastructure: Networked folders for instrument access and data storage established; consolidated dataset of available methods by technique, range/purpose, and make/model created.
Workforce Development: Job descriptions finalized; two analytical PDRs recruited and onboarded to support operations.
Collaborations & Integration: VACoE positioned as a primary resource for PMCM Analytical Characterization and leveraged for Gates Foundation‑supported studies.
Dissemination: Poster presented at NIIMBL National Meeting (June 2024); review article published on vaccine manufacturing and analytics.
Foster, R., Palakollu, V., Roberts, C., Pluschkell, S., & Buckland, B. (2024).Vaccine Analytics Center of Excellence. Poster presented at the 2024 NIIMBL National Meeting, June 25–27, 2024, Capital Hilton, Washington, D.C.
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