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

将基于近红外光谱的过程分析技术与 Omega-3 磷脂药品的小规模连续制造过程相结合

基本信息

批准号：
543888-2019
负责人：
Ismail, Ashraf
金额：
$ 11.7万
依托单位：
McGill University
依托单位国家：
加拿大
项目类别：
Collaborative Research and Development Grants
财政年份：
2019
资助国家：
加拿大
起止时间：
2019-01-01 至 2020-12-31
项目状态：
已结题

来源：
https://www.nserc-crsng.gc.ca/ase-oro/Details-Detailles_eng.asp?id=693918
关键词：
Integration Near Infrared Spectroscopy Based

项目摘要

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.

目前制药公司用于液体药品质量保证和工艺优化的质量控制方法需要使用湿化学和色谱方法，这些方法非常耗时，并且在某些情况下会导致生产效率降低。发送到配备先进仪器的外部实验室，导致产品发布进一步延迟（最多 8-21 天），因此，制药公司需要实施在线过程分析技术来解决 NSERC 下的上述问题。 -从事总部位于魁北克的制药公司发起了一项与 Ashraf Ismail 教授（麦吉尔大学）的合作研究（2018 年），以调查利用近红外光谱来监测源自磷虾油的活性药物成分的制造过程的可行性。可行性研究是开发基于近红外（NIR）光谱的初步校准模型，用于测定生产过程中原材料和中间体中的关键成分。计划在 NSERC-CRD 拨款的支持下扩大与麦吉尔大学的合作，以通过光谱和质谱技术全面表征最终产品 (API) 制造过程中提取的磷虾油馏分。需要开发和验证强大的近红外校准模型，用于在活性药物成分的连续生产过程中的四个关键点进行在线监控，这项协作研发汇集了来自麦吉尔大学和来自一个研究中心的主动团队成员。魁北克的制药创新者拥有创新实施基于近红外光谱的过程分析技术所需的补充专业知识。