SBIR Phase II: New ingredients technology to enhance the safety, quality, and value of active substances for pharmaceuticals, food, and personal care

这个小型企业创新研究(SBIR)第二阶段项目的更广泛影响/商业潜力将通过一项专利技术实现，该技术具有非凡的能力，能够为制药、食品和个人护理产品提供大量高价值、难以配制的活性成分。在制药和个人护理行业，这项技术能够增溶和使难溶于水的药物物质达到增强疗效、改善安全性和降低成本的目的。此外，通过激活潜在有效但难以处理的化学实体，它可能会有力地支持药物发现和开发的长期活动。通过支持新药开发和降低制造成本，这项技术将造福公众健康，同时为该行业创造商业价值。在食品和补充剂行业，这项技术可能使行业用天然和健康的替代品取代不健康的甚至危险的添加剂，如人造色素和防腐剂，从而大大有助于长期的食品安全和保障以及公众健康。为了实现商业化的成功，已经建立了坚实的知识产权组合。经验丰富的商界领袖将与知名科学家合作，将尖端技术应用于药品、食品和营养以及个人护理产品。拟议的项目将极大地支持这项新技术的发展。这项技术瞄准的核心问题/机会是大量高价值但水溶性较差的活性成分，这些成分长期以来一直挑战着制药和食品行业。例如，现代药物发现技术确定的候选药物中，约有80%的水溶性很差。对于食物来说，大量的维生素、营养素、抗氧化剂和天然色素的水溶性很差。总体而言，难于溶于水的化合物构成了一个巨大的配方挑战。为了满足这一需求，该团队创建了一种高效且非特定的平台技术。该项目的目标是进一步开发技术，扩大核心材料的合成，获得关于其安全性的数据，并通过向潜在客户提供原型来推进商业化活动。这个项目将通过初创公司、一所主要大学以及一些主要的制药、配料、食品和个人护理公司之间的密切合作来进行。该项目的交付内容包括提供给客户的核心材料规格、初步安全评估和原型。该项目将支持初创公司为商业化和长期成长奠定坚实的基础。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project will be accomplished through a proprietary technology with its extraordinary capability to enable a large number of high-value, hard-to-formulate active ingredients for pharmaceutical, food, and personal care products. In the pharmaceutical and personal care industries, this technology is able to solubilize and enable poorly water-soluble drug substances to achieve enhanced therapeutic effect, improved safety profile, and reduced cost. In addition, it may strongly support the long-term activities of drug discovery and development through activating potentially efficacious, but hard-to-handle chemical entities. By supporting new drugs development and reducing manufacturing cost, this technology will benefit the public health and meanwhile create commercial values to the industry. In the food and supplement industries, this technology may enable the industry to replace non-healthy or even hazardous additives, such as artificial colors and preservatives, with natural and healthy alternatives, thus greatly contribute to long-term food safety and security as well as public health. To achieve commercialization success, a solid portfolio of intellectual properties has been established. Seasoned business leaders will work with renowned scientists to incorporate cutting-edge technologies into drug, food & nutrition, and personal care products. The proposed project will substantially support the development of this new technology. The core problem/opportunity this technology targets is a large number of high-value whereas poorly water-soluble active ingredients that have been challenging the drug and food industry for a long time. For example, around 80% of drug candidates identified by modern drug discovery technologies are poorly water-soluble. For food, a large number of vitamins, nutrients, antioxidants, and natural colors are poorly water-soluble. Overall, poorly water-soluble compounds constitute an enormous formulation challenge. To address this need, this team has created a platform technology that is highly effective and non-specific. The goal of this project is to further develop the technology, scale up the synthesis of a core material, obtain the data on its safety profile, and advance the commercialization activities by providing prototypes to potential customers. This project will be conducted through close collaborations among the start-up company, a major university, and a number of major pharmaceutical, ingredients, food, and personal care companies. The deliverables of this project include the specifications of core material, initial safety evaluations, and prototypes provided to customers. This project will support the start-up company to form a solid foundation for commercialization and long-term growth.