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

Questi Pharma是一家总部位于魁北克的生物制药创新公司，专注于研究和开发用于治疗心脏代谢疾病的新型磷虾油omega-3磷脂疗法。该公司的主要候选药物CaPre®是一种磷虾油衍生的多不饱和脂肪酸（PUFA）混合物，** 主要由omega-3脂肪酸EPA和DHA组成，它们以 ** 磷脂酯和游离脂肪酸的组合形式存在。对于活性药物成分的生产，Resti Pharma** 是少数几家开发了连续生产工艺的创新制药公司之一，** 而不是传统的批量生产。该公司计划在其生产线上实施基于近红外（NIR）光谱的创新过程分析技术（PAT），作为将质量纳入制造过程的一种手段。在投资这项技术之前，需要对近红外光谱可以提供的关于制造过程中每个阶段的信息进行全面评估。该 **Engage Grant将使该公司能够与麦吉尔大学的研究人员建立合作，该研究人员 ** 将采用先进的数学技术分析从制造过程中的六个点采集的样品 ** 中获得的近红外光谱数据，并将这些数据与关键 ** 分子组分的浓度相关联，这些浓度通过实验室分析和核磁共振（NMR）** 光谱确定。在完成这项研究后，Resti Pharma将获得所需的关键信息，以 ** 证明与实施过程分析技术相关的重大资本投资是合理的，** 这是一种提高加拿大卫生部，** 美国FDA和世界各地其他监管机构认可的药品质量的方法。该公司在制造业的创新将提高其在全球市场的竞争力，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。

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.