International Feasibility Study with Sri Lanka for Innovative Manufacture Facility of Retinol as a Pharmaceutical Grade API.

与斯里兰卡进行医药级原料药视黄醇创新生产设施的国际可行性研究。

• 批准号: 10020015
• 金额: $ 2.67万
• 依托单位: PHYTOCEUTICAL LIMITED
• 依托单位国家: 英国
• 项目类别: Collaborative R&D
• 财政年份: 2022
• 资助国家: 英国
• 起止时间: 2022 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=10020015
• 关键词: International; Feasibility; Study; Sri; Lanka

Phytoceutical and Regenall have formed a partnership to exploit their IP (Patent and Patent applications) and clinical trial applications (CTA) in the health and medical sectors. Core to both companies IP and CTAs is vitamin A including the form retinol (where molecular size allows skin penetration) used in skin and tissue regenerative medicine. However, retinol is reactive and unstable but Phytoceutical have, including studies with the University of Surrey and NPL, demonstrated their nano-micellar delivery platform successfully stabilises and delivers retinol into skin and tissue.Retinol is supplied by a small number of reputable global suppliers however nano technology requires a high purity grade only available from laboratory suppliers at high prices or at lower cost and quality. There is no Pharma grade readily available at a cost effective price in the form required as an active pharmaceutical ingredient (API).Conversations have taken place with the Sri Lankan High Commission with offers to support a compact modern Pharmaceutical manufacturing plant, initially for retinol API synthesis, in a Sri Lanka Free Trade Zone. This project main focus is to build international research and innovation partnerships and networks for the technical, regulatory and commercial feasibility to set up such a facility.Key objectives include researching freedom to operate i.e. existing IP/patents to guide inventive synthesis approach.Technical: Research the feasibility with local Universities of novel retinol synthesis from local produce for a new Pharma grade.Regulatory: Research and conduct due diligence with the Sri Lanka medical regulator NMRA and UK regulator MHRA for facility Pharma GMP approval in Sri Lanka for API to be used in UK Pharma product manufacture for UK and EU markets with future steps to manufacture these for local and Asian markets in Sri LankaCommercial: Due diligence to be conducted and meeting with potential local interested parties including State Pharmaceutical Corporation and Board of Investment. Sri Lanka needs new high tech industries and support is willing but requires interaction on the ground.High-tech compact facility for synthesising retinol as an API for UK manufacture and export is innovative, extending facility in future to produce nano-micellar IP protected products to Pharma GMP for Sri Lankan and Asian markets brings innovative manufacturing to the local country supporting hi value jobs and exports. Benefits accrue back to the UK supporting product manufacture in UK for global EU and USA markets, creating jobs and tax revenue in the UK.

Phytoceutical 和 Regenall 建立了合作伙伴关系，以在健康和医疗领域开发其知识产权（专利和专利申请）和临床试验应用 (CTA)。 IP 和 CTA 两家公司的核心都是维生素 A，包括用于皮肤和组织再生医学的视黄醇形式（分子大小允许皮肤渗透）。然而，视黄醇具有反应性且不稳定，但 Phytoceutical 与萨里大学和 NPL 的研究表明，他们的纳米胶束递送平台成功稳定视黄醇并将视黄醇递送到皮肤和组织中。视黄醇由少数信誉良好的全球供应商提供，但纳米技术需要高纯度等级，只能以高价格或以较低的成本和质量从实验室供应商处获得。目前还没有以具有成本效益的价格提供活性药物成分 (API) 所需形式的医药级产品。已与斯里兰卡高级专员公署进行了对话，并提出支持斯里兰卡自由贸易区的一个紧凑型现代制药厂，最初用于视黄醇 API 合成。该项目的主要重点是建立国际研究和创新合作伙伴关系和网络，以实现建立此类设施的技术、监管和商业可行性。主要目标包括研究操作自由，即现有知识产权/专利，以指导创造性合成方法。技术：与当地大学研究从当地产品合成新型视黄醇用于新医药级的可行性。监管：与斯里兰卡进行研究和尽职调查 医疗监管机构 NMRA 和英国监管机构 MHRA 已批准斯里兰卡工厂 Pharma GMP，将 API 用于英国和欧盟市场的英国制药产品生产，未来将采取措施为斯里兰卡本地和亚洲市场生产这些产品。商业：将进行尽职调查，并与包括国家制药公司和投资委员会在内的潜在当地利益相关方会面。斯里兰卡需要新的高科技产业，并且愿意提供支持，但需要实地互动。用于合成视黄醇作为英国制造和出口原料药的高科技紧凑设施是创新的，未来将扩大设施，为斯里兰卡和亚洲市场生产符合制药 GMP 的纳米胶束知识产权保护产品，为当地带来创新的制造，支持高价值就业和出口。收益将返回英国，支持英国为全球欧盟和美国市场制造产品，在英国创造就业机会和税收。