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**与 Iris 一起成长**。 2024 年春季，我们将为 12 个月以上儿童推出一款植物性、不含添加成分的强化成长饮料。我们专为免疫功能低下和以植物为基础的儿童而设计。联合创始人 Amy 的女儿 Iris 患有多种食物过敏，她是我们的灵感来源。我们的最终目标是创造一种基于植物的低过敏性婴儿配方奶粉，提供一种通用的、现成的、营养丰富的选择。它将使需要替代饮食的婴儿，尤其是无法母乳喂养的婴儿茁壮成长。如果英国要提供包容性的喂养选择，我们的创新至关重要。然而，目前还没有注册用于婴儿配方奶粉的低过敏性蛋白质。我们的目标是成为改变世界的市场竞争者，但在支持安全有效的婴儿营养产品的有力证据和支持性监管授权方面没有捷径。该项目是获得注册所需的几个创新步骤中的第一个用于婴儿配方奶粉的替代性低过敏性蛋白质。它将导致进一步的创新工作，包括授权档案和临床试验，以证明适用性和增长的验证，然后我们才能进行蛋白质来源授权和最终在目标市场（英国、欧盟、美国）的注册，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，制定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，并将支持进入市场的监管授权。作为研究的一部分，我们将找到最合适的植物性蛋白质来源。将召开科学研讨会来审查收集的证据和数据包提案，以提供验证和发布的输出。它旨在为政府食品/医疗保健战略提供信息，强调为婴儿提供更具包容性的营养选择。 我们可发表的研究可能成为一种催化剂——开辟更多的研究机会，改变对替代蛋白质、未来政府健康战略以及医疗保健、医疗专业人员和公众知识的思考。政府食品战略审查建议政策举措应促进健康、可持续性、饮食的可及性并确保食品供应，“提供安全、健康、负担得起的食品；无论（人们）住在哪里或赚多少钱。”由于牛奶是全球儿童中最常见的食物过敏，并且植物性生活的趋势不断增长，因此需要做出改变来挑战和颠覆静态的行业和当前有限的选择。