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

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.