Integration of Near-Infrared Spectroscopy-Based Process Analytical Technology with a Bench-Scale Continuous Manufacturing Process for an Omega-3 Phospholipid Pharmaceutical Product

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Current QC methods employed by pharmaceutical companies for quality assurance and process optimization of liquid-based pharmaceutical products entail the use of wet-chemical and chromatographic-based methods which are time consuming and can lead to reduced production efficiency. In some cases, the samples are sent to external labs that are equipped with advanced instrumentation which causes further delays in product release (up to 8-21 days). Accordingly, there is a need for pharmaceutical companies to implement online process analytical technologies to address the above drawbacks. Under an NSERC-Engage grant (2018), a Quebec-based pharmaceutical company initiated a collaborative study with Professor Ashraf Ismail (McGill University) to investigate the feasibility of implementing near-infrared spectroscopy to monitor the manufacturing process for an active pharmaceutical ingredient derived from krill oil. The outcome of the feasibility study was the development of preliminary near-infrared (NIR) spectroscopy-based calibration models for the determination of key components in the starting material and intermediates in the production process. Based on the positive outcome of the study, the company plans to expand its collaborative efforts with McGill University under the auspices of an NSERC-CRD grant to fully characterize the krill oil fractions, extracted during the manufacture of the final product (API), by both spectroscopic and mass-spectrometric techniques. The NSERC-CRD proposal also entails the development and validation of robust NIR calibration models for on-line monitoring at four key points in the continuous manufacturing process of the active pharmaceutical ingredient. This collaborative R&D initiative bring together team members from McGill and from a Québec-based pharmaceutical innovator who have the complementary expertise required to undertake this innovative implementation of NIR spectroscopy-based process analytical technology.