Infant formula: Alternative protein study and regulatory roadmap

婴儿配方奶粉：替代蛋白质研究和监管路线图

• 批准号: 10108649
• 金额: $ 12.72万
• 依托单位: PLANT POWERED BABIES LTD
• 依托单位国家: 英国
• 项目类别: Collaborative R&D
• 财政年份: 2024
• 资助国家: 英国
• 起止时间: 2024 至 无数据
• 项目状态: 未结题
• 来源: https://gtr.ukri.org/projects?ref=10108649
• 关键词: Infant; formula; Alternative; protein; study

We are **Grow with Iris**. In spring 2024 we are launching a plant-based, free from, fortified growing up drink for children aged 12 months plus. We are made specifically for immunocompromised and plant-based children. Co-founder Amy's daughter Iris lives with numerous food allergies and is our inspiration.Our ultimate goal is to create a plant-based, hypoallergenic infant formula to provide a universal, off-the-shelf, nutritionally capable option. It would enable babies needing alternative diets to thrive, especially infants unable to be breastfeed. Our innovation is vital if the UK is to deliver inclusive feeding options. However, there is currently no hypoallergenic protein registered for use in infant formula. We aim to become a world-changing, market contender, but there are no shortcuts in terms of robust evidence to support safe and efficacious infant nutrition products and the supporting regulatory authorisation.This project is the first of several innovative steps required to gain the registration of an alternative, hypoallergenic protein for use in infant formula. It would lead on to further innovative work including an authorisation dossier and clinical trial to prove validation of suitability and growth, before we could work on the protein source authorisation and eventual registration in target markets (UK, EU, US) to enable us to commercialise our products. Our project will draw together leading experts in academia, clinical, government and industry fields to produce a feasibility study and regulatory roadmap to explore suitability, ensure efficacy and safety and will support regulatory authorisation to access markets. As part of the study, we would find the most suitable plant-based source of protein. A scientific workshop will be convened to review gathered evidence and data package proposals to provide validation and the outputs published. It aims to inform government food/healthcare strategy, highlighting more inclusive nutrition options for infants. Our publishable study could become a catalyst -- opening up more research opportunities, creating a shift in thinking about alternative proteins, future government health strategies and the knowledge of healthcare, medical professionals and the public. The government food strategy review suggests policy initiatives should boost health, sustainability, accessibility of diets and secure food supply that "Delivers safe, healthy, affordable food; regardless of where (people) live or how much they earn." With cow's milk being the most common global food allergy in children and a growing trend in plant-based living, change is needed to challenge and disrupt a static industry and the current limited options.

我们**随着鸢尾花的成长**。在2024年春季，我们为12个月以上的儿童推出了一个基于植物的植物，没有强化的生长饮料。我们是专门为免疫功能低下和植物性儿童而制造的。联合创始人艾米（Amy）的女儿艾里斯（Iris）以多种食物过敏而生活，这是我们的灵感。我们的最终目标是创建一个基于植物的，低过敏的婴儿配方，以提供一种通用的，现成的，营养具有营养能力的选择。这将使需要替代饮食的婴儿能够壮成长，尤其是婴儿无法母乳喂养的婴儿。如果英国要提供包容性喂养选择，我们的创新至关重要。但是，目前尚未在婴儿配方中使用低过敏性蛋白质。我们的目标是成为改变世界的市场竞争者，但是在有力的证据方面，没有任何捷径可以支持安全有效的婴儿营养产品和支持的监管授权。该项目是获得替代性的，低过敏性蛋白质供婴儿配方的替代性蛋白质所需的几个创新步骤中的第一个。这将导致进一步的创新工作，包括一项授权档案和临床试验，以证明对适用性和增长的验证，然后我们才能在目标市场（美国，欧盟）进行蛋白质来源授权和最终注册，以使我们能够商业化我们的产品。 我们的项目将汇集学术界，临床，政府和行业领域的领先专家，以进行可行性研究和监管路线图，以探索适用性，确保有效性和安全性，并将支持对进入市场的监管授权。作为研究的一部分，我们会发现最合适的植物性蛋白质来源。将召集一个科学研讨会，以审查收集的证据和数据包建议，以提供验证和发布的输出。它旨在为政府食品/医疗保健策略提供信息，突出针对婴儿的包容性营养选择。 我们可发布的研究可能成为催化剂 - 开放更多的研究机会，在思考替代蛋白质，未来的政府健康策略以及医疗保健，医疗专业人员和公众的知识方面发生了转变。政府食品战略审查表明，政策举措应促进健康，可持续性，饮食的可及性和安全的食品供应，“提供安全，健康，负担得起的食物；无论（人们）居住或赚多少钱。”由于牛奶是儿童中最常见的全球食品过敏，并且在基于植物的生活中的趋势不断增长，因此需要变革来挑战和破坏静态行业和当前有限的选择。