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Vaccine Manufacturing and Analytical Characterization Program

Mission

Accelerate the implementation of new vaccine manufacturing technologies across multiple platform processes by addressing workforce and technology issues that U.S. and global vaccine manufacturers and suppliers face and establishing a Center of Excellence for Vaccine Analytics and Assays.

Vision

Accelerate the production of innovative vaccines by ensuring that both U.S.-based and global vaccine manufacturers and suppliers have adequate support to implement advanced manufacturing and product characterization processes.

A row of vials on an assembly line

How Will Advances in Vaccine Manufacturing and Analytical Characterization Benefit the Industry?

  • The Vaccine Manufacturing and Analytical Characterization Program brings together stakeholders and resources to identify opportunities to collaboratively advance manufacturing-related issues relevant to the development and distribution of vaccines. Such advances can help make vaccines more quickly and widely available to a broad U.S. population and positively impact U.S. preparedness and response to future pandemics.
  • The Program also aims to address the technology and workforce needs of vaccine companies, suppliers, and contributing technology developers in the United States while serving the interests of the global community through additional support from the Bill and Melinda Gates Foundation.

Vaccine Manufacturing and Analytical Characterization Program Structure

Enabling Resources

Vaccines Analytics and Assays Center

Objective: Develop a facility and equipment available for NIIMBL members to assess techniques and facilitate training and knowledge sharing

Solution / Purpose
  • Will include a suite of instruments for characterization of a range of quality attributes (e.g., potency, stability, AA/sterility, physical or chemical properties, solid state) across different vaccine modalities and sample sources (e.g., mRNA and lipid nanoparticles [LNPs], virus-like particles [VLPs])
  • Will be used as a test bed, providing a non-competitive test bed space for training program and analytics development (not a contract testing laboratory)
Outcomes / Impacts
  • 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 overall U.S. preparedness and response to future pandemics.
  • The project will enable unprecedented collaboration opportunities for vaccine innovators, small and medium manufacturers, and academics to converge on key techniques and fill gaps for making vaccines more quickly and widely available to a broad U.S. population.
Next Generation Sequencing Lab

Objective: Evaluate next-generation sequencing (NGS) as a rapid alternative assay for in vivo and in vitro adventitious virus testing for vaccine safety

Solution / Purpose
  • Compare NGS-based methods with in vitro cell culture and in vivo animal assays
  • Develop a well-qualified reference virus database (RVDB II) for accurate interpretation of NGS data
Outcomes / Impacts
  • Reduction in the use of animals for adventitious agent testing
  • Streamlining and standardization of bioinformatics analysis pipeline
  • Reduced cost and time of adventitious virus testing, leading to more rapid product development

Progress and updates

High-level program timeline

Program Participants

NIIMBL Co-Leads

Barry Buckland Executive Director

Barry Buckland

Executive Director
Christopher J. Roberts, Associate Institute Director

Christopher Roberts

Associate Institute Director

Stefanie Pluschkell, Senior Fellow

Stefanie Pluschkell

NIIMBL Senior Fellow

NIIMBL Scientific Program Manager

Ryan Foster, NIIMBL Scientific Program Manager

Ryan Foster

Scientific Program Manager

More NIIMBL-led programs

Big Data

The program focuses on five key areas — standardization and contextualization, end-to-end automated control of critical quality attributes (CQAs), multivariate sensors and analytics, advanced control strategies, and bioprocess modeling and simulation – that will enable biomanufacturers to harness the power of data for real-time decision-making.

Viral Vector

This program’s work aims to establish industrially relevant NIIMBL platform processes for AAV and LV production that could significantly enhance access to and utility of viral vectors for gene-based therapeutic research and development.

Process Intensification

The NIIMBL community is collaborating on an integrated approach to create flexibility, improve control and security of the supply chain, foster sustainability, and reduce costs in biopharmaceutical manufacturing.

Learn more and get involved

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Access more program information, including:

  • Program charters
  • Roadmaps and webinars
  • Roster of leadership and participants
  • Program progress reports and workshop results

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