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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.
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