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Suggested Citation:"Appendix A Statement of Task." National Research Council. 2010. Considerations for Ensuring Safety and Efficacy of Vaccines and Therapeutic Proteins Manufactured by Using Platform Approaches: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/12899.
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Appendix A Statement of Task An ad hoc committee will plan and conduct a public workshop that focuses on the manufacturing process and specifically on the development of "manufacturing platforms"—repeatable components of manufacturing that aim to reduce both development time and risk of vaccines and therapeutic proteins (e.g., monoclonal antibodies) targeted at specific agents within a few months after these agents are identified. This is important because a major component of the U.S. Department of Defense (DoD)/Transformational Medical Technologies Initiative (TMTI) efforts in biodefense is to develop vaccines and therapeutic proteins (e.g., monoclonal antibodies) targeted at specific agents within a few months after agents are identified. The workshop will feature invited presentations and discussions on various topics addressing integrated platforms to produce safe and efficacious surrogate countermeasures in contexts that are expected to mimic those of future threat agents and that could shorten the regulatory approval process. The agenda will include manufacturing-related characteristics of monoclonal antibodies and vaccines that confer safety and efficacy, attempting to highlight the most important critical quality attributes (CQAs) that stem from these characteristics and discussion of the extent to which these CQAs could form a basis for assuring production of safe and efficacious vaccines against novel agents, facilitating rapid approval of DoD countermeasure products by the FDA. It will also include the impact of the identified CQAs on the development/planning of manufacturing platforms and integration across multiple platforms, asking what should be considered in the development of manufacturing platforms to maximize the potential for consistency between existing and new monoclonal antibodies and vaccines. Additional discussion will center on whether there are characteristics of diseases or vaccines that will more readily lead to consistency between surrogate and new vaccines. 16

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A major goal of the US Department of Defense (DOD) Transformational Medical Technologies Initiative (TMTI) is to develop countermeasures that will protect military personnel against bioweapons, including specific infectious-disease agents and toxins. An explicit TMTI objective is to respond quickly to such threats by producing an appropriate amount of an effective countermeasure--currently defined as enough material to treat or vaccinate 3 million personnel--within 12 months of identification of a specific threat. DOD officials call for TMTI programs to be up and running by 2014.

The National Academies hosted a workshop which brought together scientists from academe, government, and the biotechnology industry to identify and discuss challenges and ideas related to the TMTI's vision of developing countermeasures within a few months after an agent is identified. The workshop focused on manufacturing processes and specifically on the development of "manufacturing platforms"--repeatable components of manufacturing that reduce both development time and risk. An underlying assumption was that demonstrating that integrated platforms can reliably produce safe and efficacious countermeasures might shorten the regulatory approval process. The workshop is summarized in this book.

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