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单抗工艺相关杂质分析
释义
单抗工艺相关杂质分析
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医学
单克隆抗体检定
释
process related impurity analysis of monoclonal antibody
单抗工艺相关杂质分析
对单抗生产过程中产生的来自培养细胞(宿主细胞蛋白、宿主细胞DNA等)、培养基和下游工艺(试剂、层析柱相关物质等)的相关杂质,采用适当的经过验证的方法进行评估和分析,供试品测定结果应在该产品规定的范围内。
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culture of eucheumatoidae
culture of Fenneropenaeus chinensis
culture of freshwater shrimp
culture of Gadus macrocephalus
culture of Gracilaria tenuistipitata
culture of Gracilariopsislemaneiformis
culture of Haliotis discus hannai
culture of Haliotis diversicolor
culture of Holothuria scabra
culture of honor
culture of hybrid grouper
culture of large yellow croaker culture
culture of Larimichthys crocea
culture of law
culture of Litopenaeus vannamei
culture of lotus
culture of Lutjanus erythopterus
culture of Megalobrama amblycephala
culture of Meretrix meretrix
culture of mollusc
culture of Mugil cephalus
culture of mussel
culture of Oplegnathusfasciatus
culture of Oplegnathus punctatus
culture of Pampus argenteus
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