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
Wellesley Treateutics Inc.是一家总部位于多伦多的制药公司,目前销售两种含有终极氨基葡萄糖®和Villicote®商标的GlcNAc(GlcNAc)产品。卫尔斯理目前对GlcNAc的提纯工艺需要使用多步骤、有机溶剂为基础的提取和沉淀方法。这种方法成本高,对环境有负面影响,而且存在安全问题--需要昂贵的防爆处理。韦尔斯利正在寻求与Seneca的生物科学和应用化学学院(BSAC)合作,采用一种绿色化学方法来回收和提纯产品。这种方法将结合GlcNAc的物理溶解性质,消除与有机溶剂相关的沉淀。
韦尔斯利致力于治疗多发性硬化症、肌营养不良症和帕金森病的GlcNAc的临床开发。声称这些适应症的治疗将要求卫尔斯理提交新药申请。本申请要求详细描述物理和化学制造过程以及生产控制。在Seneca进行的实验工作将转化为对计划中的商业生产方法的详细描述和理由
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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