EFFICIENT SCALE-UP OF IPS CELLS FOR AUTOLOGOUS CELL THERAPY WORKFLOW
高效扩大 IPS 细胞的自体细胞治疗工作流程
基本信息
- 批准号:10822298
- 负责人:
- 金额:$ 27.56万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2023
- 资助国家:美国
- 起止时间:2023-09-15 至 2024-08-31
- 项目状态:已结题
- 来源:
- 关键词:AutologousBenchmarkingBiologicalBioreactorsCell CountCell Culture TechniquesCell DeathCell TherapyCellsClinicalComplexCyclic GMPDevelopmentDevicesDoseEngineeringFeedbackFlow CytometryFutureGenerationsGerm CellsGoalsHarvestHealthcare SystemsHumanIn VitroKaryotype determination procedureLaboratoriesLinkMaintenanceManualsMarketingMeasurementMedicineModelingNutrientOutcomeOutputParacrine CommunicationPatientsPerfusionPharmaceutical PreparationsPhasePhysiologicalPopulationPositioning AttributeProcessProviderQuality ControlResearchSamplingSerum-Free Culture MediaSmall Business Innovation Research GrantStructureSuspensionsTechniquesTechnologyTimeTissue Culture TechniquesTissuesTrainingTranslatingTranslationsUniversitiesVariantWorkcell typeclinical predictorsclinically relevantcommercial applicationcostcost efficientdesignexperimental studyhealth care economicsimprovedin silicoinduced pluripotent stem cellinnovationmanufacturing processpluripotencyprecision medicinepreservationprototypescale upshear stressstemstem cell expansionsuccessthree dimensional cell culturetimelineuser-friendly
项目摘要
Project Summary/Abstract
Cell expansion is a critical step for cell therapy, hindered by expensive and complex bioreactor requirements to
yield sufficient cell numbers for adequate dosing and requiring expensive regents to enhance functionality for
increased clinical success. To support the use of patient cells within the cell therapy workflow, there is a need
for bioreactors designed for expanding patient cells from an initial iPS clonal population to clinically relevant cell
doses. These reactors must also be suitable for cGMP processes and economically efficient to enable their utility
within the healthcare system. Overall, there is a need for clinically relevant cell expansion technologies that are
robust and efficient enough to enable the realization of autologous cell therapy workflows as a viable treatment
option for all. Thus, the unmet need we will address is providing a bioreactor-based workflow for the efficient
translation of patient cells into high-quality iPS cell based therapeutics in a patient-specific manner – benefiting
drug developers, patients, clinicians, and the healthcare economy. Our universal approach to cell expansion
(OnXpansion) uses a defined serum-free media and relies on controlled aggregation for enhanced paracrine
signaling and cell-cell contact, enhanced nutrient delivery via low-shear perfusion, and organotypic tissue niches
to generate thousands of identical spheroid tissues that can be further scaled to yield adequate cell numbers
for cell therapy at both reduced costs and manual labor. Our approach to translating this technology center
around de-risking its utility for precision medicine and increasing its suitability and handling within the intended
customer workflows. Our bioreactor products are efficient (cost, time, labor), easy to use, automated, reliable,
robust, physiologically relevant, and clinically predictive. The large unmet need and low barrier for entry positions
Link favorably against competitors. Overall, Link’s products are designed to enable a reliable and robust
precision medicine workflow that is efficient and of high biological fidelity, thereby enabling a future where cell
therapy is more accessible to the patient, via decreased costs, and the provider, via simplified workflows.
项目总结/文摘
项目成果
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Kacey Ronaldson其他文献
Kacey Ronaldson的其他文献
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{{ truncateString('Kacey Ronaldson', 18)}}的其他基金
EFFICIENT DIFFERENTIATION, SCALE-UP, AND MATURATION OF IPS DERIVED CARDIOMYOCYTES
IPS 来源的心肌细胞的有效分化、放大和成熟
- 批准号:
10761485 - 财政年份:2023
- 资助金额:
$ 27.56万 - 项目类别:
CELL EXPANSION BIOREACTORS FOR ASSAY-READY IMMUNOCOMPETENT PATIENT MODELS
用于检测准备的免疫功能正常患者模型的细胞扩增生物反应器
- 批准号:
10688981 - 财政年份:2023
- 资助金额:
$ 27.56万 - 项目类别:
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