I-Corps Teams: Membrane Adsorbers for Biologics Purification

癌症和心血管疾病等慢性病发病率的上升正在推动对用于治疗这些疾病的生物药物的需求。目前，美国有130多种生物制品被批准使用，市场价值超过140美元。针对100多种疾病的900多种新生物制品正在开发中。新产品的商业化将需要大幅扩大生产能力和提高制造灵活性，以满足未来的市场需求。此外，生物仿制药、生物制剂的出现和日益激烈的竞争将给生物制药商带来经济压力，要求它们创新药物制造技术，以降低生产成本。下游药物提纯尤其需要创新，这往往限制了生产能力，占总制造成本的30%-40%。这个i-Corps团队正在开发一个平台(PuriTM膜)，以显著提高生物药物下游提纯的生产能力和灵活性。PuriTM平台的一次性性质预计将显著降低生物制造生产成本。该项目预计将通过开发i-Corps团队的创业知识和技能，加快PuriTM膜创新的市场进入，这些知识和技能是将创新从学术实验室转化为行业部门所需的。PuriTM吸附膜组件是净化生物药物的一次性膜产品。它们的特点是高药物结合能力、高选择性和对原料条件的高度耐受性。实验室研究表明，第一代PuriTM膜专门解决了所有已知的客户痛点。通过客户访谈和商业模式画布的使用，该团队将测试这样一个命题，即这些一次性使用的吸附膜创新将从它们提高生物制造设施的生产能力和灵活性以及降低生物制剂的制造成本的能力中获得商业价值。早期验收客户的确定也是该项目的一个结果。该团队将开发阿尔法原型，并与潜在客户密切合作，对这些原型进行外部验证。外部验证的完成将为团队提供更多机会，以了解客户需求并测试有关产品实用性和设计的假设。它还将提供重要数据，以吸引外部投资者和新客户。在i-Corps计划结束时，预计会有一个经过验证的商业计划和最低限度的可行产品。

Rising rates of chronic conditions such as cancer and cardiovascular diseases are driving the demand for biologic drugs used to treat them. Currently, there are over 130 biologics approved for use in the US, with a market exceeding $140 B. Over 900 new biologics targeting more than 100 diseases are under development. New product commercialization will require significant expansions in production capacity and improvements in manufacturing flexibility to meet future market demands. In addition, the emergence of biosimilars, biobetters, and increasing competition will apply economic pressure on biomanufacturers to innovate new drug manufacturing technologies to lower production costs. Innovations are especially needed in downstream drug purification, which often limits the production capacity and contributes 30-40% of the overall manufacturing cost. This I-Corps team is developing a platform (PuriTM membranes) to dramatically enhance production capacity and flexibility in the downstream purification of biologic drugs. The disposable nature of the PuriTM platform is expected to reduce biomanufacturing production costs significantly.This project is expected to accelerate market entry of PuriTM membrane innovations by developing the entrepreneurial knowledge and skills of the I-Corps team that are needed to translate the innovation from the academic laboratory to the industry sector. PuriTM adsorptive membrane modules are single-use membrane products that purify biologic drugs. They are characterized by high drug binding capacity, high selectivity, and high tolerance to feedstock conditions. Laboratory research has demonstrated that the firstgeneration PuriTM membranes specifically address all of the known customer pain points. Through customer interviews and use of the business model canvas, the team will test the proposition that these single-use adsorptive membrane innovations will derive commercial value from their abilities to increase the production capacity and flexibility of biomanufacturing facilities and lower the manufacturing cost of biologics. Identification of early acceptance customers also is expected as an outcome of the project. The team will develop alpha prototypes and work closely with potential customers on external validation of these prototypes. Completion of external validation will provide additional opportunities for the team to understand customer needs and test assumptions about the product utility and design. It also will provide vital data to attract external investors and new customers. A validated business plan and minimum viable products areexpected at the end of the I-Corps program.