WTEC International Assessment of Rapid Vaccine Manufacturing

Final Report

The WTEC expert panel's final report of its international assessment of rapid vaccine manufacturing is available for download in low-resolution PDF format. For a printed hard copy of the report, please contact WTEC.

Workshop: International Assessment of Research & Development in Rapid Vaccine Manufacturing

Our panel of experts completed an international assessment of the foremost labs in Europe.

Their findings were presented at a final workshop held at the National Science Foundation (Stafford II, Room 555) in Arlington, Virginia, on March 30, 2007.  

Presentations from the final workshop (Europe).

Workshop on Science and Technology in North American Rapid Vaccine Manufacturing

This "baseline" initial workshop was held on January 23, 2006, NSF, Arlington, VA (Room 110, Stafford I)

• Agenda and presentations from the baseline workshop (North America)

Introduction

The threat of avian influenza to produce a pandemic among humans has brought to the fore the pressing need for advances in rapidly responsive vaccine development, manufacture and distribution.  According to a National Academy of Sciences Report, identification of a viral strain may take as long as six to eight months with additional months required to produce and distribute effective vaccine.  Standard methods for production of vaccine were developed more than 50 years ago.  Many modern methods, materials, and processes can enable improvement of the present situation.

The solution to providing a rapid response with the production and deployment of therapeutic immunization requires cross-cutting research in manufacturing, biomedical engineering, systems modeling and other disciplines, as well as quality standards, clinical testing and education of responders and the general public.

Need for an International Study

The WTEC assessment will inform biomedical engineering, manufacturing engineering and other  related disciplines with respect to future research initiatives that may help address bottlenecks in the R&D and manufacturing chain necessary to address the problems of rapid development and large-scale manufacturing and of distribution of new vaccines.  The results will provide guidance to R&D program managers worldwide, including those in the U.S. National Science Foundation and National Institutes of Health, as well as other agencies of the Department of Health and Human Services (e.g., FDA, CDC), the Department of Homeland Security, and the Department of Defense. The information will also be provided to international organizations concerned with public health.

Key questions that will be directly addressed in this evaluation include the following:

1. What is the status of international R&D on rapid vaccine manufacturing and the development-deployment systems chain? 
2. How do U.S. activities in this area compare to those of other countries?
3. What ideas from overseas are worth exploring in U.S. R&D programs, and vice versa?
4. What technologies will pay off, and what are the needs for government promotion of general progress in vaccine manufacturing?
5. What opportunities exist for international collaboration?

Purpose

The goal of this study is to gather information on the worldwide status and trends in vaccine manufacturing R&D, and to disseminate it to government decision makers and the research community.

The study panelists will gather information on research abroad, which will be useful to the U.S. Government in its own programs.  The study will critically analyze and compare the research in the United States with that being pursued in Japan, Europe, and  other selected countries.  This information will serve the following purposes:

• Identify good ideas overseas worth exploring in U.S. R&D programs.
• Clarify research opportunities and needs for promoting progress in the field.
• Identify specific opportunities (persons and institutions) for international collaboration.
• Evaluate the position of foreign research programs relative to those in the U.S.

Scope

The scope of the study, subject to modification by the sponsors, will focus on the following important topics:

• Assessment of engineering R&D for flexible, scalable, modular vaccine manufacturing that could provide rapid response to the needs of both the general public or to smaller regional outbreaks of disease.  Agricultural vaccine will be considered as well because of the demands for massive inoculation of domestic fowl and animals from which applicable lessons may be learned.
• Assessment of vaccine production methods for optimum compatibility with flexible, scalable manufacturing.  Methods of separation, purification, quality control, etc. will be reviewed.   Which technologies can deliver the desired ability to rapidly scale and manufacture?
• Assessment of rapid evaluation of vaccine effectiveness.  What should be tested?  What are possible useful surrogates and models for the population to receive vaccination? 

Additional Topics and Issues

Other topics may be added to the study scope based on discussion among expert panelists and the sponsors of the study.  Some additional topics to be considered could include the following:

• How can the technology response be matched to the appearance of the threat?  A lot might be learned from various countries’ responses to local disease threats, e.g., Russia and tick borne encephalitis disease.  What is the interface between local and global vaccine/immunization programs?  Rapid spread of disease could be addressed as another aspect of globalization.
• How might the deployment/delivery phase for vaccines be improved?  Issues of storage, shelf-life, stability, delivery methods should be reviewed.  How does the manufacturing decision effect the supply chain?
• Level of resources by government and industry for research on vaccine production.
• Adequacy of existing and planned manufacturing facilities.

The following topics, subtopics, issues and themes have been suggested for coverage for coverage in the study.

• Experience of Federal research with rotavirus
• Manufacturing processes with scalability for large production
• Surge capabilities
• Manufacturing process for small scale disease prevention
• Flexible manufacturing capabilities
• Storage and extending shelf life
• Production problems
• Adjuvants
• Fill and finish
• Intellectual property
• Manufacturers’ liability problems
• Use of microfluidics
• Standards and measurement capability: overcome in-process, in situ measurement barriers
• Flow fermentation systems
• Protein manufacturing
• Health care modeling, primary health care delivery mechanisms
• Realistic risk modeling and public education
• Modeling of predictive toxicology
• Business modeling, public funding and purchasing
• Vaccine distribution and delivery methods
• Newer technologies: platforms, recombinant systems, animal testing methods
• Nanoscale technologies
• Long term strategies for effective research and development: road mapping

Panelists