The biopharmaceutical industry is a growing market relying on analytical methods to bring safe and efficacious drugs from conception to market. Analytical methods are required during the entire drug life cycle as it plays a vital role during decision making. Impurities influence product quality, stability and efficacy, so their levels need to be minimised. There are regulatory guidelines that set out principles for consideration in meeting product quality specifications. Analytical methods have limits in their sensitivity and accuracy of measurement, their sample throughput and/or range of detection. This highlights the need to have orthogonal assays that can confidently quantify critical impurities to the appropriate levels. In this review, we discuss three major analytically challenging critical quality attributes – two product related impurities (aggregates and incorrect glycosylation) and one process related impurity (host cell proteins) – and the analytical assays that are commonly used to measure their quantity and quality.

生物制药行业是一个不断增长的市场，它依赖于分析方法将安全有效的药物从概念推向市场。在整个药物生命周期中都需要分析方法，因为它在决策过程中起着至关重要的作用。杂质会影响产品质量，稳定性和功效，因此需要将其含量降至最低。有法规指南规定了在满足产品质量规格时要考虑的原则。分析方法在灵敏度和测量精度，样品通量和/或检测范围方面有局限性。这突出显示了需要进行正交分析以可靠地将关键杂质定量到适当水平的需求。在这篇评论中，