Non-organic Solvent Method of Extracting N-Acetyl glucosamine from a fermentation broth
Non-organic Solvent Method of Extracting N-Acetyl glucosamine from a fermentation broth
批准号:
555617-2020
负责人:
Leaver, Chad
金额:
$1.03万
依托单位国家:
加拿大
项目类别:
Applied Research and Development Grants - Level 1
财政年份:
2020
资助国家:
加拿大
项目状态:
已结题
起止时间:
2020-01-01 至 2021-12-31
中文摘要
韦尔斯利治疗公司,是一家总部位于多伦多的制药公司,目前销售两种含有GlcNAc(GlcNAc)的产品,商品名为Ultimate Glucosamine®和Villicote®。韦尔斯利目前的GlcNAc纯化工艺需要使用多步、基于有机溶剂的萃取和沉淀方法。这种方法成本高,对环境有负面影响,并且有安全问题-需要昂贵的防爆处理。韦尔斯利希望与塞内卡生物科学与应用化学学院(BSAC)合作,采用绿色化学方法进行产品回收和纯化。该方法将结合GlcNAc的物理溶解度性质以消除对有机溶剂相关沉淀的需要。
韦尔斯利从事GlcNAc治疗多发性硬化症、肌肉萎缩症和帕金森病的临床开发。声称治疗这些适应症将要求韦尔斯利提交新药申请。本申请要求详细描述物理和化学制造工艺以及生产控制。在Seneca进行的实验工作将转化为预期商业生产方法的详细描述和原理
英文摘要
Wellesley Therapeutics Inc., is a Toronto-based pharmaceutical company, currently marketing two GlcNAc (GlcNAc) containing products under the trade name Ultimate Glucosamine® and Villicote®. Wellesley's current purification process for GlcNAc requires the use of a multistep, organic solvent based, extraction and precipitation methodology. This method is costly, has negative effects on the environment and has safety concerns - expensive explosion proof processing is required. Wellesley is looking to collaborate with Seneca's School of Biological Sciences and Applied Chemistry (BSAC) to adopt a green chemistry approach to product recovery and purification. This approach will incorporate the physical solubility properties of GlcNAc to eliminate the need for organic solvent associated precipitation.
Wellesley is engaged in the clinical development of GlcNAc for multiple sclerosis, muscular dystrophy and Parkinson's disease. Claims for the treatment of these indications will require Wellesley to file a new drug application. This application requires a detailed description of physical and chemical manufacturing processes and controls for production. The experimental work carried out at Seneca will translate to a detailed description and rationale for the intended commercial production methods
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