Clinical Testing of the First Suspension BHK-M Cell Platform Derived Biotherapeutic
第一个悬浮 BHK-M 细胞平台衍生的生物治疗药物的临床测试
基本信息
- 批准号:9759962
- 负责人:
- 金额:$ 75.21万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2012
- 资助国家:美国
- 起止时间:2012-08-01 至 2022-07-31
- 项目状态:已结题
- 来源:
- 关键词:AntibodiesBiological Response Modifier TherapyBiological SciencesBiomanufacturingBiomedical EngineeringBioreactorsBlood Coagulation FactorBusinessesCanadaCapitalCaringCell LineCellsChemistryClinicalComplicationConsumptionContractsCountryData AnalysesDevelopmentDevelopment PlansDocumentationDoseEconomicsF8 geneFactor VIIIFamily suidaeFeedbackGoalsHalf-LifeHamstersHemophilia AHemorrhageHumanImmune ToleranceInfusion proceduresInsuranceInternationalInvestmentsIowaKidneyLabelLaboratoriesLegal patentM cellMaterials TestingMethodsMulticenter TrialsNational Heart, Lung, and Blood InstituteNeoadjuvant TherapyPatientsPersonsPharmaceutical PreparationsPharmacology and ToxicologyPhasePoliciesPopulationPreventionProcessProductionProductivityProteinsProtocols documentationR-factorRecombinantsRecordsRecoveryReportingResearchResourcesRunningSafetySerumServicesSmall Business Innovation Research GrantSuspensionsSystemTechnologyTechnology TransferTeenagersTestingTherapeuticTreatment EfficacyTreatment FactorWestern EuropeWorkbarrier to carecell bankclinical developmentclinical materialcommercializationcostdesignfirst-in-humanimprovedinhibitor/antagonistinnovationmeetingsnoveloff-patentopen labelpreclinical developmentprimary endpointprogramsrecombinant antihemophilic factor VIIIresearch clinical testingsafety studystability testingtherapy design
项目摘要
PROJECT SUMMARY/ABSTRACT
The long-term objective of current project is to commercialize a novel coagulation factor product manufactured
using a novel production cell line, designated ET3i/BHK-M with a primary indication of treatment of anti-drug
antibodies that develop following the treatment of congenital hemophilia A with factor VIII (fVIII) replacement
products. Expression Therapeutics has developed multiple technologies that, when integrated, provide a highly
efficient biomanufacturing platform designed for improved volumetric productivity. In the phase I SBIR project
periods, Expression Therapeutics generated and validated a research cell bank demonstrating the highest levels
of recombinant factor VIII reported to date, completed upstream and downstream process development, and
successfully transferred the technology to a contract manufacturing organization for production of phase I clinical
test material. The current application seeks to complete all manufacturing, nonclinical, clinical planning, and
regulatory activities required to conduct a phase I first-in-man trial of ET3i/BHK-M, with the primary endpoint of
safety and tolerability.
项目总结/摘要
本项目的长期目标是将生产的新型凝血因子产品商业化。
使用命名为ET3i/BHK-M的新生产细胞系,其主要适应症为抗药物治疗,
用因子VIII(fVIII)替代治疗先天性血友病A后产生的抗体
产品. Expression Therapeutics开发了多种技术,当这些技术整合在一起时,
高效的生物制造平台,旨在提高体积生产率。在SBIR项目第一阶段,
期间,Expression Therapeutics生成并验证了一个研究细胞库,该细胞库显示出最高水平
已完成上游和下游工艺开发,以及
成功地将该技术转让给合同生产组织,用于生产I期临床
试验材料。当前应用程序旨在完成所有制造、非临床、临床计划和
进行ET3i/BHK-M I期首次人体试验所需的监管活动,主要终点为
安全性和耐受性。
项目成果
期刊论文数量(0)
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Gabriela Denning其他文献
Gabriela Denning的其他文献
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{{ truncateString('Gabriela Denning', 18)}}的其他基金
Manufacturing Process Development for Bioengineered FVIII
生物工程 FVIII 的制造工艺开发
- 批准号:
8454386 - 财政年份:2013
- 资助金额:
$ 75.21万 - 项目类别:
Bioengineered factor VIII gene therapy for hemophilia A
针对血友病 A 的生物工程因子 VIII 基因治疗
- 批准号:
8313425 - 财政年份:2012
- 资助金额:
$ 75.21万 - 项目类别:
Development of a novel production platform for complex recombinant biotherapeutic
开发复杂重组生物治疗的新型生产平台
- 批准号:
8251701 - 财政年份:2012
- 资助金额:
$ 75.21万 - 项目类别:
Bioengineered factor VIII gene therapy for hemophilia A
针对血友病 A 的生物工程因子 VIII 基因治疗
- 批准号:
8714274 - 财政年份:2012
- 资助金额:
$ 75.21万 - 项目类别: