Biomaterial Manufacturing Suite in Support of NIH/NIAID and the Global Infectious Disease Research Community

支持 NIH/NIAID 和全球传染病研究界的生物材料制造套件

• 批准号: 10795293
• 负责人: Rebecca Bradford
• 金额: $ 479.83万
• 依托单位: AMERICAN TYPE CULTURE COLLECTION
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-06 至 2026-11-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10795293
• 关键词: Acceleration; American Type Culture Collection; Biocompatible Materials; Biological; Biological Products; COVID-19 pandemic; Communities; Containment; Development; Disease Outbreaks; Federal Government; Funding; Goals; Growth; Health; Human; Infectious Diseases Research; Longevity; Modernization; National Institute of Allergy and Infectious Disease; Nonprofit Organizations; Organism; Pathogenicity; Production; Public Health; Reproducibility; Research; Resources; Translational Research; United States National Institutes of Health; Variant; Virginia; cost; design; design and construction; detection assay; epidemic potential; manufacture; manufacturing capabilities; medical countermeasure; pandemic potential; priority pathogen; programs; service programs; therapeutic development; vaccine development

Biomaterial Manufacturing Suite in Support of NIH/NIAID and the Global Infectious Disease Research Community PROJECT DIRECTOR: REBECCA BRADFORD, MBA, MS, PMP® Project Summary The project is to construct and commission a Biomaterial Manufacturing Suite (BMS) as an expansion within the High Containment Facility (HCF) currently under design at the American Type Culture Collection (ATCC). ATCC is a non-profit entity in Manassas, Virginia, serving the Federal Government for over 50 years through our Federal Solutions (AFS) Division. The proposed aim of the BMS is to provide modern and reproducible large-scale biomaterial manufacturing capabilities for priority pathogens. Residing within the soon-to-be-built HCF, the BMS will offer the National Institute of Health and the National Institute of Allergy and Infectious Diseases (NIH/NIAID) high-throughput and rapid development pipelines for biomaterials of public health concern, including those of epidemic or pandemic potential. The BMS will directly support Federal Agencies and the infectious disease research communities by optimizing pathogenic organisms’ growth, production, and characterization for downstream use. By funding the BMS within the planned facility, AFS can enhance our support to NIH/NIAID through our ability to offer large-scale stocks of well-characterized challenge materials at no cost to the research community through AFS managed programs, including BEI Resources. In turn, this will accelerate infectious disease research for vaccine and therapeutic development in outbreak situations and serve as biological standards for developing detection assays. AFS’ current modular 7,500 ft2 HCF was built in 2007 as a temporary solution to facilitate the expanding needs of AFS’ Health and Human Services (HHS) programs. The facility is now over- extended with respect to lifespan, capacity, and capabilities. AFS dutifully maintains the upkeep of the current HCF to support the extensive NIH/NIAID requests for biological products to advance our medical countermeasures and arsenal against variants for the recent onslaught of the COVID- 19 pandemic. As a non-profit organization, ATCC has committed several million dollars to design and construct a new HCF to enhance and modernize our support to NIH. The explicit goal of this funding is to include the design, construction, and commissioning of the BMS within the facility footprint to provide critical biological manufacturing capabilities in the biomedical space to accelerate translational research for vaccine and therapeutic development.

支持 NIH/NIAID 和全球传染病的生物材料制造套件 疾病研究团体 项目总监：丽贝卡·布拉德福德 (REBECCA BRADFORD)，MBA、MS、PMP® 项目概要 该项目旨在建造并调试生物材料制造套件（BMS）作为 美国核电站目前正在设计的高密闭设施 (HCF) 内的扩建 典型培养物保藏中心（ATCC）。 ATCC 是一个位于弗吉尼亚州马纳萨斯的非营利实体，为 50 多年来，我们一直通过我们的联邦解决方案 (AFS) 部门为联邦政府服务。这 BMS 的拟议目标是提供现代且可复制的大规模生物材料 优先病原体的生产能力。位于即将建成的 HCF 内， BMS 将向美国国立卫生研究院和国立过敏和传染病研究所提供 疾病（NIH/NIAID）公共生物材料高通量快速开发管线 健康问题，包括流行病或大流行潜力的问题。 BMS将直接支持 联邦机构和传染病研究界通过优化致病菌 供下游使用的生物体的生长、生产和表征。通过资助 BMS 在计划的设施内，AFS 可以通过提供以下服务的能力来加强对 NIH/NIAID 的支持： 大量库存的特征明确的挑战材料，研究界无需支付任何费用 通过 AFS 管理的计划，包括 BEI Resources。反过来，这将加速传染 疾病暴发情况下的疫苗和治疗开发研究，并作为 开发检测分析的生物学标准。 AFS 目前的模块化 7,500 平方英尺 HCF 建于 2007 年，作为临时解决方案，以促进 AFS 健康与人类服务 (HHS) 计划的需求不断扩大。该设施现已超 在寿命、容量和功能方面得到延长。 AFS 尽职尽责地进行维护 当前的 HCF 支持 NIH/NIAID 对生物制品的广泛要求，以推进 我们的医疗对策和武器库针对最近新冠病毒的猛烈攻击 19 流行病。作为一个非营利组织，ATCC 投入了数百万美元来设计 建立一个新的 HCF，以加强我们对 NIH 的支持并使之现代化。此次活动的明确目标 资金将包括设施内 BMS 的设计、建造和调试 足迹在生物医学领域提供关键的生物制造能力 加速疫苗和治疗开发的转化研究。