Feasibility of Near-Infrared Spectroscopy as a Process Analytical Tool for Inline/Online Control of Manufacturing of an Omega-3 Phospholipid Concentrate Pharmaceutical Product

近红外光谱作为 Omega-3 磷脂浓缩药品生产在线/在线控制过程分析工具的可行性

• 批准号: 530992-2018
• 负责人: Ismail, Ashraf
• 金额: $ 1.82万
• 依托单位: McGill University
• 依托单位国家: 加拿大
• 项目类别: Engage Grants Program
• 财政年份: 2018
• 资助国家: 加拿大
• 起止时间: 2018-01-01 至 2019-12-31
• 项目状态: 已结题
• 来源: https://www.nserc-crsng.gc.ca/ase-oro/Details-Detailles_eng.asp?id=654339
• 关键词: Feasibility; Near; Infrared; Spectroscopy; Process

Acasti Pharma is a Quebec-based biopharmaceutical innovator focused on the research and development of**new krill oil-based forms of omega-3 phospholipid therapies for the treatment of cardiometabolic diseases. The**company's lead drug candidate, CaPre®, is a krill oil-derived mixture of polyunsaturated fatty acids (PUFAs),**primarily composed of the omega-3 fatty acids EPA and DHA, which are present as a combination of**phospholipid esters and free fatty acids. For production of the active pharmaceutical ingredient, Acasti Pharma**is among the few innovative pharmaceutical companies to have developed a continuous manufacturing process,**as opposed to traditional batch manufacturing. The company has plans to implement innovative process**analytical technology (PAT) based on near-infrared (NIR) spectroscopy on its production line as a means of**building quality into the manufacturing process. Before investing in this technology, a full assessment of the**information that NIR spectroscopy can provide about each stage in the manufacturing process is required. This**Engage Grant will enable the company to establish a collaboration with a McGill University researcher who**will employ advanced mathematical techniques to analyze the NIR spectroscopic data acquired from samples**taken at six points in the manufacturing process and correlate these data with the concentrations of key**molecular components, as determined by laboratory analyses and by nuclear magnetic resonance (NMR)**spectroscopy. Upon completion of this research, Acasti Pharma will have the critical information needed to**justify the significant capital investment associated with implementation of process analytical technology,**which is an approach to improving the quality of pharmaceutical products that is recognized by Health Canada,**the U.S. FDA, and other regulatory agencies around the world. The company's innovations in manufacturing**will increase its competitiveness in the global marketplace, resulting in the creation of new jobs and stimulating**growth of the biopharmaceutical sector in Canada.

Acasti Pharma 是一家总部位于魁北克的生物制药创新公司，专注于研究和开发**新的基于磷虾油的 omega-3 磷脂疗法，用于治疗心脏代谢疾病。**公司的主要候选药物 CaPre® 是一种治疗心脏代谢疾病的药物。源自磷虾油的多不饱和脂肪酸 (PUFA) 混合物**主要由 omega-3 脂肪酸 EPA 和 DHA 组成，它们以**磷脂的组合形式存在对于活性药物成分的生产，Acasti Pharma** 是少数开发出连续生产工艺的创新制药公司**，与传统的批量生产相反，该公司计划实施创新工艺。 **生产线上基于近红外 (NIR) 光谱的分析技术 (PAT)，作为**将质量融入制造过程的手段。在投资该技术之前，请对 NIR 光谱的信息进行全面评估。可以提供有关制造过程中每个阶段的信息这项**参与资助将使公司能够与麦吉尔大学的研究人员建立合作关系，该研究人员**将采用先进的数学技术来分析从制造过程中的六个点采集的样品**获得的近红外光谱数据并进行关联。这些数据包含通过实验室分析和核磁共振 (NMR)** 光谱确定的关键**分子成分的浓度。完成这项研究后，Acasti Pharma 将获得**证明重要资本合理性所需的关键信息。与实施过程分析相关的投资技术**是一种提高药品质量的方法，受到加拿大卫生部、**美国 FDA 和世界各地其他监管机构的认可。该公司在制造方面的创新**将提高其在全球的竞争力。市场，从而创造新的就业机会并刺激**加拿大生物制药行业的增长。