A high-efficiency, low-cost, single-use purification technology for therapeutic antibody manufacturing

用于治疗性抗体制造的高效、低成本、一次性纯化技术

• 批准号: 10256230
• 负责人: Sarah E Bondos
• 金额: $ 81.88万
• 依托单位: BONDWELL TECHNOLOGIES LP
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-01 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10256230
• 关键词: Adoption; Affinity Chromatography; Antibodies; Antibody Therapy; Autoimmune Diseases; Binding; Binding Proteins; Bioreactors; Cell Culture Techniques; Cells; Chimeric Proteins; Chromatography; Cytolysis; Data; Development; Disease; Dose; Electrospinning; Enzymes; Fermentation; Fiber; Generations; Goals; Immunoglobulin G; Industrialization; Industry; International; Interview; Lead; Licensing; Literature; Marketing; Membrane; Methods; Monoclonal Antibodies; Pain; Performance; Phase; Plant Resins; Production; Property; Proteins; Protocols documentation; Publications; Publishing; Recovery; Research; Risk; Sales; Source; Techniques; Technology; Testing; Texas; Therapeutic Monoclonal Antibodies; Therapeutic antibodies; Universities; Water; base; cancer type; clinical efficacy; commercialization; cost; crosslink; experience; flasks; improved; industry partner; manufacturing facility; meetings; monomer; new technology; novel; novel therapeutics; operation; phase 1 study; polypeptide; preference; prevent; scale up; success; symposium; technology validation; ward

Therapeutic antibodies have had a profound impact on treatment of many types of cancer and autoimmune diseases with many new therapeutics in development. However, antibodies are extremely expensive to produce, and large amounts of antibody are required to achieve clinical efficacy. In our 268 interviews with industry experts and extensive research of the literature, Protein A-based purification is the largest pain point in mAb manufacturing. The Protein A market was $600 million in 2019 and is projected to grow to over $1 billion by 2026. This market can be divided into the classical resins that have dominated the market and new alternatives which include membranes. There is a strong desire to move away from resins; however, a lack of alternatives with superior performance have prevented this. Our Phase I data demonstrate that we have considerable advantages over incumbent suppliers by providing a high binding capacity, high-flow, single-use membrane that doesn’t rely on crosslinking. At the end of Phase II, we will produce our minimally viable product: a low-cost, high-capacity, single-use antibody purification membrane that has been validated by key industry players and ready to be displayed internationally. To do this we will accomplish the following Aims: 1) Industrial Scale Production of protein monomers 2) Optimize efficiency of electrospun membrane 3) Testing with Industry Partners. The slow adoption rate of new technologies, preference for brand reputation, compliance with FDA SOPs, global supply risk, and long runway to revenue lead to start-ups similar to ours being acquired before any sales occur. Therefore, our goal is not to manufacture and sell this product but to pursue an early exit through licensing, partnership with, or acquisition by, established companies. To accomplish this, we will leverage the data generated from industry partners during this Phase II proposal to generate high profile scientific publications and presentations at leading conferences.

治疗性抗体对许多类型癌症的治疗产生了深远的影响 自身免疫性疾病，有许多新的治疗方法正在开发中。然而，抗体是 生产成本极其昂贵，需要大量的抗体才能实现临床 功效。在我们对行业专家的268次采访和对文献的广泛研究中， 以蛋白A为基础的纯化是单抗生产中最大的痛点。蛋白A市场 2019年为6亿美元，预计到2026年将增长到10亿美元以上。这个市场可以是 分为主导市场的经典树脂和新的替代品 包括膜。人们强烈希望摆脱树脂；然而，缺乏 性能出众的替代方案阻止了这一点。我们的第一阶段数据表明 与现有供应商相比，我们有相当大的优势，因为我们提供了高约束能力， 高流量、不依赖于交联剂的一次性膜。在第二阶段结束时，我们将 生产我们最低限度可行的产品：低成本、高容量、一次性使用的抗体纯化 已通过主要行业参与者验证并准备展示的薄膜 在国际上。为此，我们将实现以下目标：1)工业规模生产 蛋白质单体2)优化电纺膜效率3)工业测试 搭档。新技术的采用率缓慢，对品牌声誉的偏好， 遵守FDA的SOP，全球供应风险，以及通往收入的漫长道路导致初创企业 类似于我们在任何销售发生之前被收购。因此，我们的目标不是制造 并销售此产品，但通过许可、合作或收购来寻求及早退出 老牌公司。为了实现这一点，我们将利用工业产生的数据 合作伙伴在这一第二阶段提案期间制作备受瞩目的科学出版物和 在主要会议上发表演讲。