,

Joshua Shipman1, Mercy Oyugi1,2, Tim Andres Marzan1

  • 1Office of Pharmaceutical Quality Research, Center for Drug Evaluation and Research, US Food and Drug Administration, Saint Louis, MO 63110, USA.

PubMed
概括

多属性方法 (MAM) 显示出在生物制药分析中取代传统质量控制 (QC) 方法的潜力. 跨实验室和仪器的验证证实了它对量化治疗蛋白质属性的能力.

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