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

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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.