CBDContiCryst2 - Scale-Up of Continuous Crystallization Process for CBD Isolate Production

CBDContiCryst2 - CBD 分离物生产连续结晶工艺的放大

• 批准号: 84373
• 金额: $ 12.17万
• 依托单位: NITECH SOLUTIONS LIMITED
• 依托单位国家: 英国
• 项目类别: Collaborative R&D
• 财政年份: 2020
• 资助国家: 英国
• 起止时间: 2020 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=84373
• 关键词: CBDContiCryst2; Scale; Up; Continuous; Crystallization

Pharmaceutical industry supply chains have been seriously impacted by the Covid-19 pandemic, with active ingredients and much formulation work currently off-shored. This is resulting in an urgent re-thinking of future supply-chain strategy both in Europe and in the USA, which will inevitably result in efforts to re-shore processes previously off-shored. Whilst a part of this expected change can be absorbed by excess capacity, industry will not want to build new batch capacity that is already obsolete, but rather move towards cutting edge, continuous manufacturing technologies as soon as possible. Reshoring of generic drugs in particular will require the use of Advanced Manufacturing technologies (including continuous process technology) to compete with existing low-cost, but high risk, supply chains.NiTech Solutions has developed patented, state-of-the-art continuous reactor technology (COBC/R) which is gaining commercial traction in both pharmaceutical and specialty chemical industries. However, the reactor also has the capability to operate continuous crystallizations, and whilst continuous crystallizations have been demonstrated for a large range of compounds at small-scale in the laboratory, it has not yet been commercially adopted, despite the fact that crystallization is very common in the purification operations of the pharmaceutical industry.This project has been developed to demonstrate continuous crystallization in an emerging segment of the healthcare industry where there is an immediate need: the extraction of pure cannabidiol (CBD) from hemp-derived distillate, a process for which we have recently received a large number of commercial enquiries. Production of high purity CBD Isolate in large volumes, low cost, and with minimal environmental impact will facilitate it's use in an increasingly broad range of products from healthcare to food & beverage. A 2018 report from the WHO outlined the health benefits of CBD in treatment of epilepsy and other medical conditions: in 2019 the US CBD market grew over 700% and the global CBD market is already worth \>$3 billion. However, the technology for crystallization of CBD remains at an elementary, batch stage, severely limiting the scale-up of production and the speed to market of CBD Isolate and therefore CBD Isolate containing products. Accordingly, the key objective of this project is to demonstrate the feasibility of employing NiTech's COBC technology in the crystallization of CBD isolate from an industry-supplied distillate, and to quantify the benefits of this process in terms of throughput, quality, safety, overall cost, and environmental impact versus traditional batch production processes. The operating boundaries of the process will be explored and optimised during the work program and output data used to inform design of our industrial scale CBD crystallization units.NiTech will work, in this project, with the Institute of Biological, Environmental and Rural Sciences (IBERS) group within the University of Aberystwyth (UA). IBERS have extensive experience in processing bio-based materials and are able to handle hemp and hemp derived CBD.NiTech and IBERS combined capabilities and competence will provide the full range of knowhow required to develop material and process parameters to deliver the desired product attributes and process performance using NiTech's COBC technology platform.

制药行业供应链受到新冠肺炎大流行的严重影响，活性成分和许多配方工作目前都在海外。这导致欧洲和美国都迫切需要重新思考未来的供应链战略，这将不可避免地导致以前离岸的流程重新岸上的努力。虽然这种预期变化的一部分可以被过剩的产能吸收，但行业不会想要建立已经过时的新批量产能，而是希望尽快转向尖端的连续制造技术。仿制药的回流尤其需要使用先进的制造技术（包括连续工艺技术）来与现有的低成本但高风险的供应链竞争。尼泰克解决方案公司开发了专利的、最先进的连续反应器技术（COBC/R），该技术在制药和特种化工行业都获得了商业吸引力。然而，反应器也具有操作连续结晶的能力，虽然连续结晶已在实验室中小规模地用于大范围的化合物，但它尚未被商业采用，尽管结晶在制药工业的纯化操作中非常常见。该项目的开发是为了在医疗保健行业的一个新兴领域展示连续结晶，该领域迫切需要：从大麻衍生馏出物中提取纯大麻二酚（CBD），我们最近收到了大量的商业咨询。大量生产高纯度的CBD分离物，低成本，对环境的影响最小，将有助于其在从医疗保健到食品和饮料的越来越广泛的产品中使用。世卫组织2018年的一份报告概述了CBD在治疗癫痫和其他疾病方面的健康益处：2019年，美国CBD市场增长了700%以上，全球CBD市场已经价值30亿美元。然而，CBD的结晶技术仍处于初级批量阶段，严重限制了CBD分离物的生产规模和上市速度，因此也限制了含CBD分离物产品的上市速度。因此，该项目的主要目标是证明采用NiTech的COBC技术从行业提供的馏出物中分离CBD结晶的可行性，并量化该工艺与传统批量生产工艺相比在吞吐量、质量、安全性、总体成本和环境影响方面的优势。该工艺的操作边界将在工作计划和输出数据中进行探索和优化，这些数据用于指导我们工业规模CBD结晶装置的设计。在这个项目中，NiTech将与阿伯里斯特威斯大学（UA）的生物、环境和农村科学研究所（IBERS）小组合作。IBERS在处理生物基材料方面有丰富的经验，能够处理大麻和大麻衍生的CBD。NiTech和IBERS的综合能力和能力将提供开发材料和工艺参数所需的全方位专业知识，以使用NiTech的COBC技术平台提供所需的产品属性和工艺性能。