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

phytoceeutical和Regenall已结成伙伴关系，在卫生和医疗领域利用其知识产权（专利和专利申请）和临床试验申请（CTA）。两家公司的IP和cta的核心是维生素A，包括视黄醇（其分子大小允许皮肤渗透），用于皮肤和组织再生医学。然而，视黄醇具有反应性和不稳定性，但Phytoceutical公司（包括萨里大学和国家物理实验室的研究）已经证明，他们的纳米胶束输送平台成功地稳定并将视黄醇输送到皮肤和组织中。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的等级，只有实验室供应商才能以高价或较低的成本和质量获得。作为活性药物成分（API）所需的形式，没有现成的具有成本效益的价格的制药级产品。与斯里兰卡高级专员公署进行了对话，提议支持在斯里兰卡自由贸易区建立一个紧凑的现代制药工厂，最初用于视黄醇原料药的合成。该项目的主要重点是建立国际研究和创新伙伴关系和网络，以实现建立这样一个设施的技术、监管和商业可行性。主要目标包括研究操作自由，即现有的知识产权/专利，以指导创造性的合成方法。技术方面：与当地大学合作研究以当地农产品为原料合成新型视黄醇的可行性。监管：与斯里兰卡医疗监管机构NMRA和英国监管机构MHRA进行研究和尽职调查，以获得斯里兰卡制药GMP批准，用于英国和欧盟市场的英国制药产品生产，未来将为斯里兰卡当地和亚洲市场生产这些产品。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，我们愿意提供支持，但需要在实地进行互动。高科技紧凑型设施用于合成视黄醇作为英国制造和出口的原料药是创新的，未来将扩展设施以生产纳米胶束知识产权保护产品，为斯里兰卡和亚洲市场提供制药GMP，为当地国家带来创新制造业，支持高价值就业和出口。这些好处会回馈给英国，支持英国为全球欧盟和美国市场生产产品，在英国创造就业机会和税收收入。

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.