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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：
Kacey Ronaldson
金额：
$ 27.56万
依托单位：
LINK BIOSYSTEMS INC.
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：
https://reporter.nih.gov/project-details/10822298
关键词：
Autologous Benchmarking Biological Bioreactors Cell Count Cell Culture Techniques Cell Death Cell Therapy Cells Clinical Complex Cyclic GMP Development Devices Dose Engineering Feedback Flow Cytometry Future Generations Germ Cells Goals Harvest Healthcare Systems Human In Vitro Karyotype determination procedure Laboratories Link Maintenance Manuals Marketing Measurement Medicine Modeling Nutrient Outcome Output Paracrine Communication Patients Perfusion Pharmaceutical Preparations Phase Physiological Population Positioning Attribute Process Provider Quality Control Research Sampling Serum-Free Culture Media Small Business Innovation Research Grant Structure Suspensions Techniques Technology Time Tissue Culture Techniques Tissues Training Translating Translations Universities Variant Work cell type clinical predictors clinically relevant commercial application cost cost efficient design experimental study health care economics improved in silico induced pluripotent stem cell innovation manufacturing process pluripotency precision medicine preservation prototype scale up shear stress stem stem cell expansion success three dimensional cell culture timeline user-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