Reducing the prohibitive costs of protein production for therapeutic development

降低用于治疗开发的蛋白质生产成本

• 批准号: 10588188
• 负责人: Ryan W. Shepherd
• 金额: $ 50万
• 依托单位: PHYLLOTECH, LLC
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-02-05 至 2025-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10588188
• 关键词: Adoption; Agrobacterium; Amino Acids; Antibodies; Biological Assay; Businesses; Catalogs; Codon Nucleotides; DNA Integration; Engineering; Environment; Enzyme-Linked Immunosorbent Assay; Friends; Future Generations; Generations; Genetic; Harvest; Marketing; Mediating; Methods; Patients; Plant Leaves; Plants; Positioning Attribute; Price; Production; Proteins; Protocols documentation; Reagent; Research; Savings; Shuttle Vectors; Soil; Source; Specific qualifier value; Sterility; Structure; Surface; System; Techniques; Technology; Testing; Therapeutic; Therapeutic antibodies; Tobacco; Western Blotting; Work; commercialization; cost; cytokine; design; glycosylation; manufacture; manufacturing technology; new epidemic; novel; operation; plant growth/development; protein purification; research and development; scale up; therapeutic development; tissue culture; tool; tool development; vector

PhylloTech, Inc. is redefining the production of proteins and antibodies by eliminating the need for expensive manufacturing, purification, and downstream processing steps. The company has developed a contrarian method to produce proteins and antibodies in plants by engineering tobacco leaf structures, called glandular secreting trichomes, to manufacture, purify, and deliver target proteins directly to leaf surfaces of living plants for easy and economical harvests. The proteins can then be packaged and sold directly to the end user or sent to fill/finish operations. The value proposition is that high amounts of purified proteins can be generated at low cost in a renewable, environmentally friendly manner. We call this expression system OnLeafEX, and with this system, PhylloTech can eliminate the prohibitive costs that are forestalling the future generation of protein-based therapeutics. We are pursuing the cytokine research use only market segment as an immediate opportunity because of their restrictively high costs, high demand, and overseas sourcing. The specific aims of the project are: Specific Aim 1 – Genetic sequences encoding twenty-five cytokines will be designed and codon-optimized for N. tabacum, and placed into proprietary plant vectors. Specific Aim 2 - Stable plant transformants will be generated with standard protocols of Agrobacterium-mediated plant transformation. Specific Aim 3 - Propagated plants will then be transferred to sterile soil and grown in our indoor plant growth facility, and plant-made cytokines will be harvested. Specific Aim 4 – Harvested plant-made cytokines will be internally validated and analyzed. Specific Aim 5 – Plant-made cytokines will be externally validated for activity and further developed for commercialization. The aim of this work is to use a novel manufacturing technology discovered in plants to dramatically increase patient’s accessibility to therapeutics by lowering their costs, and with OnLeafEX, the company is in an ideal position to maximize this business opportunity. Research and development costs associated with cytokines and other research tools could be drastically reduced, potentially allowing for faster adoption of therapeutics. The technology will also lower the COGS for partner companies, providing larger margins and ultimately more financial stability to organizations that can pass the savings onto patients, resulting in lower retail prices for therapeutics.

PhylloTech，Inc.正在重新定义蛋白质和抗体的生产，不再需要 用于昂贵的制造、提纯和下游加工步骤。该公司拥有 开发了一种反向方法，通过工程在植物中生产蛋白质和抗体 烟叶结构，称为腺体分泌毛状体，用于制造、提纯和传递 将蛋白质直接靶向活植物的叶表面，以便于和经济地收获。这个 然后，蛋白质可以被包装并直接出售给最终用户，或者被送到灌装/完成操作中。 其价值主张是，可以在一种 可再生、环保的方式。我们称这个表达系统为OnLeafEX， 有了这个系统，PhylloTech可以消除阻碍未来的高昂成本 以蛋白质为基础的疗法的产生。我们只追求细胞因子的研究用途 将细分市场视为直接的机会，因为他们的成本非常高， 需求和海外采购。该项目的具体目标是： 具体目标1-将设计编码25个细胞因子的遗传序列并 密码子-针对烟草核糖体进行了优化，并将其置于专有的植物载体中。 特定目标2-稳定的植物转化子将通过以下标准方案产生 农杆菌介导的植物转化。 然后，将特定目标3繁殖的植株转移到无菌土壤中种植 我们的室内植物生长设施和植物制造的细胞因子将被收获。 特定的目标4-收获的植物制造的细胞因子将进行内部验证和 分析过了。 特定目标5-植物制造的细胞因子将在外部验证活性，并进一步 为商业化而开发的。 这项工作的目的是利用在工厂中发现的一种新的制造技术来 通过降低患者的成本显著增加患者获得治疗的机会，并通过 在LeafEX上，该公司处于最大限度地利用这一商机的理想位置。 与细胞因子和其他研究工具相关的研发成本可能是 大幅减少，潜在地允许更快地采用治疗方法。这项技术将 还降低了合作伙伴公司的COGS，从而提供更大的利润率，最终实现更高的利润 为能够将节省的资金转嫁给患者的组织提供财务稳定，从而降低 治疗药物的零售价。