Drug Product Services, Lonza AG, Hochbergerstrasse 60A, 4057 Basel, Switzerland; Division of Pharmaceutical Technology, Department of Pharmaceutical Sciences, University of Basel, Klingelbergstrasse 50, 4056 Basel, Switzerland.
Drug Product Services, Lonza AG, Hochbergerstrasse 60A, 4057 Basel, Switzerland.
J Pharm Sci. 2020 Jan;109(1):216-219. doi: 10.1016/j.xphs.2019.09.002. Epub 2019 Sep 12.
Cell therapy products represent an exciting new class of medicinal products, which must be parenterally administered. Thus, compliance with parenteral preparation guidelines is required. One requirement for parenteral products is the characterization of particle contaminations. As cell-based products are turbid suspensions, containing particles, the cells, characterization and control of foreign particle impurities remain a challenge. Within this study, we evaluated a flow imaging microscopy method for the detection and characterization of subvisible particle contaminations in cell-based products. We found that flow imaging microscopy is a potential method where subvisible particle contaminations can be differentiated from the cells in cell therapy products.
细胞治疗产品代表了一类令人兴奋的新型药物，必须通过注射给药。因此，必须遵守注射制剂的制备指南。注射产品的一个要求是对颗粒污染物进行特性描述。由于基于细胞的产品是含有细胞的混浊悬浮液，因此，对异物颗粒杂质的特性描述和控制仍然是一个挑战。在本研究中，我们评估了一种用于检测和描述细胞治疗产品中亚可见颗粒污染物的流动成像显微镜方法。我们发现，流动成像显微镜是一种有潜力的方法，可以将细胞治疗产品中的亚可见颗粒污染物与细胞区分开来。
