Core B: Industrialization Core
核心B:工业化核心
基本信息
- 批准号:10088388
- 负责人:
- 金额:$ 10.18万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2019
- 资助国家:美国
- 起止时间:2019-02-14 至 2024-01-31
- 项目状态:已结题
- 来源:
- 关键词:AddressAdvanced DevelopmentAntibodiesAntibody TherapyCategoriesCategory A pathogenCellsCommunicable DiseasesCrimean-Congo Hemorrhagic Fever VirusCustomDNAData SetDevelopmentDiseaseEbolaEbola virusEnsureFormulationGenesGoalsGovernmentHantavirusHealthHendra VirusHumanImmune responseIndustrializationIndustryInfectionInflammatoryInvestigational New Drug ApplicationLaboratory ProceduresLassa virusLebanonMarburgvirusMethodsMonitorMonoclonal AntibodiesMuscle CellsNational SecurityNipah VirusOncologyPatientsPharmaceutical PreparationsPharmacologic SubstancePoint MutationProcessPublic HealthRecombinantsResearch Project GrantsResourcesRiskSafetySurvivorsTechnologyTestingTherapeuticTherapeutic Monoclonal AntibodiesToxicologyUnited States Food and Drug AdministrationVaccinesViralVirulentVirusanimal efficacybasecell bankclinical developmentcross reactivityefficacy studyexpectationexperienceglycosylationhigh riskhuman tissuelead candidatemanufacturabilitymembermonoclonal antibody productionneglectpathogenpriority pathogenproduct developmentprophylacticscreening
项目摘要
ABSTRACT: CORE B
Monoclonal antibodies (mAbs) are one of the most successful classes of drugs with the proven ability to
address a variety of human health needs ranging from oncology, inflammatory diseases, and infectious
diseases. Recent studies have demonstrated efficacy of mAbs against the most virulent infections
including Nipah, Hendra, Ebola, Marburg and Lassa. Antibodies isolated from human survivors, the
focus of the Prometheus CETR, have the advantage of having been a component of a successful host
response to a pathogen. Further, these mAbs were positively selected for by the human immune
response to the target pathogen. Therefore, these survivor mAbs will have an increased chance of
being safe and efficacious compared to mAbs generated from other platforms. MAbs also offer a
stunning degree of customization based on the importance of mechanisms of action. Different classes,
sub-types, point mutations and N-glycosylation states can dramatically impact the potency of a
prophylactic or therapeutic mAb candidate. The manufacturing platforms, formulation methods, and
safety profiles of mAbs are well-established. Thus, mAbs offer a low-risk technology platform for
prophylactics and therapeutics for the Category A threats (i.e. agents that pose the highest risk to
national security and public health) to be addressed by the Prometheus CETR. Core B, in conjunction
with Research Project III, will also evaluate the use of DNA-encoded mAbs (DMAbs), a potentially
transformative technology that turns the patient’s own muscle cells into mAb producers.
The Industrialization Core (Core B) is focused on ensuring the down-selection process of the CETR
results in: 1. Manufacturable mAbs; 2. A product that satisfies the Target Product Profile (TPP); 3. Data
sets and materials (e.g. cell banks) that are appropriate and supportive of regulatory filings with the
Food and Drug Administration (FDA) to transition the products into advanced development. The
Industrialization Core has two Aims: 1) Provide product development experience to Research Projects
and the Cores to assure studies are compatible with industry and regulatory expectations, and 2)
Transition products to advanced development.
摘要:核心B
单克隆抗体(mAb)是最成功的一类药物,已证明具有以下能力:
满足各种人类健康需求,从肿瘤学,炎症性疾病,
疾病最近的研究表明,单克隆抗体对最致命的感染有效
包括尼帕、亨德拉、埃博拉、马尔堡和拉萨。从人类幸存者身上分离出的抗体,
Prometheus CETR的焦点,具有成为成功主机组件的优势
对病原体的反应此外,这些mAb被人免疫系统阳性选择。
对目标病原体的反应。因此,这些存活mAb将有增加的机会,
与从其他平台产生的mAb相比是安全和有效的。MAb还提供
基于作用机制的重要性的惊人的定制程度。不同的阶级,
亚型、点突变和N-糖基化状态可显著影响免疫调节剂的效力。
预防性或治疗性mAb候选物。生产平台、配制方法和
单克隆抗体的安全性特征已得到充分证实。因此,单克隆抗体提供了一个低风险的技术平台,
A类威胁的药物和治疗药物(即对
国家安全和公共卫生)将由Prometheus CETR解决。核心B,结合
与研究项目III,还将评估使用DNA编码的单克隆抗体(DMAbs),一个潜在的
这是一项革命性的技术,可以将患者自己的肌肉细胞转化为mAb生产者。
工业化核心(核心B)的重点是确保CETR的向下选择过程
结果表明:1.可制造的mAb; 2.符合目标产品概况(TPP)的产品; 3.数据
适用于并支持向监管机构提交的器械和材料(如细胞库)
美国食品和药物管理局(FDA)将产品过渡到高级开发阶段。的
产业化核心有两个目的:1)为研究项目提供产品开发经验
和核心,以确保研究符合行业和监管预期,以及2)
将产品过渡到高级开发阶段。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Kartik Chandran其他文献
Kartik Chandran的其他文献
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{{ truncateString('Kartik Chandran', 18)}}的其他基金
Einstein BSL3 Laboratory Renovation to Advance Biomedical Research on RNA Viruses of Pandemic Potential
爱因斯坦 BSL3 实验室改造将推进对可能引发大流行的 RNA 病毒的生物医学研究
- 批准号:
10611691 - 财政年份:2022
- 资助金额:
$ 10.18万 - 项目类别:
Comprehensive genetic dissection of poxvirus membrane assembly and function
痘病毒膜组装和功能的全面基因解剖
- 批准号:
10575027 - 财政年份:2022
- 资助金额:
$ 10.18万 - 项目类别:
Optimizing SARS-CoV-2 wastewater based surveillance in urban and university campus settings.
优化城市和大学校园环境中基于 SARS-CoV-2 废水的监测。
- 批准号:
10320993 - 财政年份:2021
- 资助金额:
$ 10.18万 - 项目类别:
Optimizing SARS-CoV-2 wastewater based surveillance in urban and university campus settings.
优化城市和大学校园环境中基于 SARS-CoV-2 废水的监测。
- 批准号:
10264634 - 财政年份:2021
- 资助金额:
$ 10.18万 - 项目类别:
Project II: Biologics Engineering and Antibody Mechanism of Action
项目二:生物制剂工程与抗体作用机制
- 批准号:
10555312 - 财政年份:2019
- 资助金额:
$ 10.18万 - 项目类别:
Prometheus: A Platform for Rapid Development of Human Antibody-based Therapeutics and Prophylactics against Emerging Viral Threats
Prometheus:快速开发针对新兴病毒威胁的基于人类抗体的治疗和预防方法的平台
- 批准号:
10088385 - 财政年份:2019
- 资助金额:
$ 10.18万 - 项目类别:
Project II: Biologics Engineering and Antibody Mechanism of Action
项目二:生物制剂工程与抗体作用机制
- 批准号:
10088393 - 财政年份:2019
- 资助金额:
$ 10.18万 - 项目类别:
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