Considerations for Ensuring Safety and Efficacy of Vaccines and Therapeutic Proteins Manufactured by Using Platform Approaches: Summary of a Workshop.

摘要

Department of Defense (DOD) is developing new efforts to protect warfighters from disease and biologic-warfare agents. The DOD Transformational Medical Technologies Initiative (TMTI) seeks to shorten the timeline for development of medical measures to counter emerging biologic-warfare threats: genetically engineered and other nontraditional toxins, virulence factors, and microorganisms. One goal of the TMTI is development of platforms for identifying unknown agents and developing countermeasures so that within five years an infrastructure will be in place for reacting quickly to a variety of threats, including agents that have been genetically engineered. Participants discussed manufacturing-related characteristics of monoclonal antibodies and vaccines. Although the planning committee understood that the TMTI efforts are broader than biologics and that TMTI platform approaches for biologics extend beyond monoclonal antibodies and vaccines, the planning committee believed that focusing on monoclonal antibodies and vaccines could illustrate some of the promise and challenges of platform approaches. This summary is based on a transcript of the workshop, and statements are attributed to specific participants according to the transcript. It is presented as a narrative rather than a strict chronology to highlight the major themes that emerged from the meeting. Views expressed in the summary are those of the individual participants and are not necessarily those of the planning committee, the National Academies, or the project sponsor.