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

Phytoceutical和Regenall已经建立了合作伙伴关系，在健康和医疗领域利用其IP（专利和专利申请）和临床试验申请（CTA）。这两家公司的IP和CTA的核心是维生素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，维生素A是反应性和不稳定的，但Phytoceutical，包括与萨里大学和NPL的研究，证明了他们的纳米胶束输送平台成功地稳定并将维生素A输送到皮肤和组织中。维生素A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，只能从实验室供应商以较高的价格或较低的成本和质量获得。目前还没有一种医药级的活性药物成分（API），其价格具有成本效益。与斯里兰卡高级专员公署进行了对话，以支持在斯里兰卡自由贸易区建立一个紧凑的现代化制药厂，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。主要目标包括研究运营自由度，即现有的IP/专利，以指导发明性合成方法。技术：与当地大学研究从当地产品合成新型视黄醇的可行性，以获得新的制药等级。监管：与斯里兰卡医疗监管机构NMRA和英国监管机构MHRA一起研究并开展尽职调查，以获得斯里兰卡工厂制药GMP批准，用于英国和欧盟市场的英国制药产品生产中使用的API，以及未来在斯里兰卡本地和亚洲市场生产这些产品的步骤商业：进行尽职调查，并与潜在的当地利益相关方会面，包括国家制药公司和投资委员会。斯里兰卡需要新的高科技产业和支持是愿意的，但需要在地面上的互动。高科技紧凑型设施合成视黄醇作为API为英国制造和出口是创新的，在未来扩展设施，以生产纳米胶束知识产权保护的产品，制药GMP为斯里兰卡和亚洲市场带来创新的制造业，以支持高价值的就业机会和出口当地国家。这些收益将返还给英国，支持英国产品制造业面向全球欧盟和美国市场，为英国创造就业机会和税收。

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.