Cash Patricia W, Narwal Roja, Levitskaya Sophia V, Krause Stephan, Murphy Derek, Mazaheri Maryam
Analytical Biotechnology, MedImmune, Gaithersburg, MD;
Formulation Sciences, MedImmune, Gaithersburg, MD; and.
PDA J Pharm Sci Technol. 2016 Mar-Apr;70(2):134-42. doi: 10.5731/pdajpst.2015.006064. Epub 2016 Jan 21.
Visible particles must be monitored as part of the control strategy for pharmaceutical products. Extraneous (foreign) particles are not acceptable in parenteral drug products. In biopharmaceuticals, formation of protein particles is recognized as an inherent quality attribute. All protein therapeutics contain particles that vary greatly in visibility and size from invisible (sub-micron) to visible (millimeter) and, as part of the control strategy, biopharmaceutical companies are required to monitor and minimize the presence of visible and sub-visible particles in their products. There is an industry-wide unmet need for particle standards for visual inspection of protein therapeutics. A new, semi-quantitative method using particle standards for assessing the levels of small, inherent visible particles is presented. This method can be used during product development to identify a formulation that minimizes particle formation and also during release and stability testing to monitor and control inherent proteinaceous visible particles.
Visible particles must be monitored as part of the control strategy for parenteral biopharmaceutical drug products. In these products, formation of protein particles is a natural occurrence. All protein drugs contain particles that vary greatly in visibility and size from invisible (sub-micron) to visible (millimeter), and pharmaceutical companies are required to monitor and minimize the presence of visible and sub-visible particles in their products. There is an industry-wide unmet need for particle standards for visual inspection of protein drugs. A new, semi-quantitative method using particle standards for assessing the levels of small, naturally occurring visible particles is presented. This method can be used during drug development to identify a formulation that minimizes particle formation and also during testing of final clinical or commercial drug product to monitor and control naturally occurring proteinaceous visible particles.
可见颗粒必须作为药品控制策略的一部分进行监测。注射用药品中不允许存在外来（杂质）颗粒。在生物制药中，蛋白质颗粒的形成被认为是一种内在的质量属性。所有蛋白质治疗药物都含有大小和可见度差异极大的颗粒，从不可见（亚微米级）到可见（毫米级），作为控制策略的一部分，生物制药公司需要监测并尽量减少其产品中可见和亚可见颗粒的存在。对于蛋白质治疗药物的目视检查，行业内对颗粒标准存在未满足的需求。本文提出了一种使用颗粒标准来评估小的、内在可见颗粒水平的新的半定量方法。该方法可在产品开发过程中用于确定能使颗粒形成最小化的配方，也可在放行和稳定性测试期间用于监测和控制内在的蛋白质可见颗粒。
可见颗粒必须作为注射用生物制药产品控制策略的一部分进行监测。在这些产品中，蛋白质颗粒的形成是自然现象。所有蛋白质药物都含有大小和可见度差异极大的颗粒，从不可见（亚微米级）到可见（毫米级），制药公司需要监测并尽量减少其产品中可见和亚可见颗粒的存在。对于蛋白质药物的目视检查，行业内对颗粒标准存在未满足的需求。本文提出了一种使用颗粒标准来评估小的、自然存在可见颗粒水平的新的半定量方法。该方法可在药物开发过程中用于确定能使颗粒形成最小化的配方，也可在最终临床或商业药品测试期间用于监测和控制自然存在的蛋白质可见颗粒。
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