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FISH方法鉴定单克隆源性
当监管部门对于申报的细胞株单克隆源性存疑的时候,可以采用有限稀释法获得亚克隆的方法来解决。但是通过额外的有限稀释来重新获得克隆细胞系既费时又昂贵,而且至关重要的是,可能会影响细胞系的生产和生长速率。当提交审核材料的时间线很短时,这是尤其不受欢迎的。荧光原位杂交(FISH)是一项功能强大的技术,可用于可视化外源基因整合位点并提供对外源基因的整合是否均一等数据和信息,在短时间内提供更直观更有说服力的数据。凭借多年的经验和深入的知识,我们可以使用荧光原位杂交(FISH)来确认转基因的整合均一性并确定其染色体带位置。北京安必奇生物科技有限公司可以通过 FISH技术提供工程生产细胞系的遗传特征数据,提供有关转基因完整性和整合位点的信息。并且我们已经为很多知名制药企业完成了工程细胞系单克隆验证(FISH)服务, 并且多家企业已经相继有对应的抗体药物已经获准上市!
北京安必奇生物科技有限公司已经搭建了专业的分子验证平台,为客户提供工程细胞单克隆性细胞库验证的服务,秉持着全球化理念,全力支持中美双报!
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