HiDef B8: Commercialization and scaled production of defined, robust, and cost-effective media for iPSCs

HiDef B8：用于 iPSC 的明确、稳健且经济高效的介质的商业化和规模化生产

• 批准号: 10405556
• 负责人: Paul W. Burridge
• 金额: $ 73.52万
• 依托单位: DEFINED BIOSCIENCE, INC.
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-05-17 至 2024-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10405556
• 关键词: Academia; Address; Adoption; Animals; Biological; Biological Assay; Biological Sciences; Cell Culture Techniques; Cell Differentiation process; Cell Line; Cell Maintenance; Cell Survival; Cells; Chemicals; Clinical; Culture Media; Development; Diet; Emerging Technologies; Evaluation; Fibroblast Growth Factor; Formulation; Genetic; Growth; Growth Factor; Heparin; Human; Industrialization; Industry; Industry Standard; Insulin; Laboratories; Literature; Mass Spectrum Analysis; Methodology; Mind; Modification; Molecular Sieve Chromatography; NRG1 gene; Names; Neuregulin 1; Outsourcing; Performance; Phase; Procedures; Production; Property; Proteins; Protocols documentation; Publishing; Recipe; Regulation; Research; Risk; Sampling; Schedule; Seasons; Serum Albumin; Serum-Free Culture Media; Small Business Innovation Research Grant; Sodium Chloride; Source; Stem Cell Development; Stem Cell Research; System; Technology; Testing; Therapeutic; Tissues; Transferrin; Undifferentiated; United States; Universities; Validation; Variant; Work; Xenobiotics; Yeasts; base; cell growth; cell type; clinical application; commercialization; cost; cost effective; design; expectation; experimental study; fetal bovine serum; improved; induced pluripotent stem cell; induced pluripotent stem cell technology; large scale production; member; pluripotency; stem cell technology; stem cells; success; sugar; trait

RESEARCH & RELATED Other Project Information Defined Bioscience, Inc. 7. PROJECT SUMMARY Inconsistency of growth media for cell culture is a significant problem in both industry and academia that has plagued laboratories for decades. In biopharma, cell-based and cell-derived therapies are growing at a tremendous rate and require well-defined, animal-free components to meet FDA and cGMP regulations. It is therefore not surprising that there is an increased need for and adoption of serum-free media for cell culture growth that is attributed to its superior batch-to-batch consistency and reduced risk of unwanted animal/xenobiotic contaminants. This is particularly critical to human induced pluripotent stem cells (hiPSCs), a rapidly evolving technology with wide research and clinical application. These cells present numerous advantages compared to previous technologies, including human origin, the ability to form multi-class cell systems and tissues, relative ease of production and modification, and functional relevance. Robust and well- characterized protocols are of utmost importance when culturing hiPSCs for downstream applications. High pluripotency, genetic stability, large-scale production and maintained function all must be kept in mind for hiPSCs. Yet despite the array of defined media now available for iPSCs, many of these media fail to satisfy the full needs of hiPSC research, including robustness over multiple passages and experimental needs, low cost, ease of production, weekend-free media changes and fully defined components. Such traits are critical for robust, consistent and affordable research in the hiPSC space. Just this year, our Defined Bioscience team empirically tested common defined media components over a large array of concentrations and combinations, isolating a well-defined recipe with high robustness, efficacy over >100 cell passages, and maintained success in a weekend-free passaging schedule. This media, termed B8 by the lab of scientific advisory board member Paul Burridge, met or exceeded the expectations for a Phase I SBIR development proposal. Here we will extend this work to prepare HiDef B8, a formulation of B8 finalized to optimal component concentrations and reduced cost. This optimized formulation will be tested across academic and industrial labs in the United States to confirm robustness and efficacy in streamlined and applied hiPSC culture and methodologies. We intend to make HiDef B8 an affordable, defined media for robust hiPSC culture across high passage numbers and in a weekend-free context, significantly reducing the cost and complexity of hiPSC technologies across the field. This will enable stable cell culture and a well-characterized starting point for subsequent differentiation and applied hiPSC technology efforts, while simultaneously lowering the barrier of entry for hiPSC development in the field.

研究及相关其他项目信息 定义的生物科学公司 7。项目摘要 增长媒体对细胞培养的不一致是行业和学术界的一个重大问题 困扰实验室数十年。在生物药物中，基于细胞和细胞衍生的疗法正在生长 巨大的速度，需要明确的，无动物的组件才能满足FDA和CGMP法规。这是 因此，毫不奇怪的是，对细胞培养的无需血清培养基的需求增加和采用 增长归因于其出色的批处理一致性和降低不需要的风险 动物/异种生物污染物。这对于人类诱导的多能干细胞（HIPSC）尤其重要 通过广泛的研究和临床应用快速发展的技术。这些细胞显示了许多 与以前的技术相比，包括人类来源的技术相比，形成多类细胞的能力 系统和组织，相对易于生产和修饰以及功能相关性。稳健 在为下游应用培养HIPSC时，特征协议至关重要。高的 多能性，遗传稳定性，大规模生产和维持功能都必须牢记 hipscs。尽管现在有一系列已定义的媒体可用于IPSC，但其中许多媒体未能满足 HIPSC研究的全面需求，包括对多个段落和实验需求的鲁棒性，低成本， 易于生产，无周末的媒体变化和完全定义的组件。这样的特征对于健壮至关重要， HIPSC领域的一致且负担得起的研究。 就在今年，我们定义的生物科学团队经验测试了大型的普通媒体组件 一系列浓度和组合，隔离具有高鲁棒性的明确定义的配方，功效 > 100个牢房通道，并在周末的传送时间表中保持成功。该媒体称为B8 科学顾问委员会成员保罗·伯里奇（Paul Burridge）的实验室达到或超出了对I期SBIR的期望 发展建议。在这里，我们将扩展这项工作以准备hidef b8，这是B8最终确定的B8的公式 组件浓度和成本降低。这种优化的配方将在学术和 美国的工业实验室确认精简和应用HIPSC文化中的鲁棒性和功效 和方法。我们打算使hidef b8成为负担得起的，定义的媒体，用于强大的HIPSC文化 高通过数字和在周末的环境中，大大降低了HIPSC的成本和复杂性 整个领域的技术。这将使稳定的细胞培养和一个特征良好的起点 随后的差异化和应用HIPSC技术努力，同时降低了 该领域HIPSC开发的条目。