摘要
根据《兽用生物制品生产用细胞系试验技术指导原则》,将BHK-21细胞原始细胞库F11代传至F52代,取其中部分代次按照《制造及检验试行规程》进行细胞形态、纯净性、胞核学检查、细胞致瘤性检验、病毒培养适应性检验。结果表明,BHK-21细胞F11~F52代各指标的鉴定结果符合规程要求。为确保细胞种子稳定性,建议疫苗生产用细胞限定在43代以内。
According to the Guidelines for Cell Line Testing Technical for the Production of Veterinary Biologi-cal Products, the BHK-21 original cell bank F11 generation was transferred to F52, and part of the generation was takenfor cell morphology, purity, cytology, tumorigenicity test and virus culture adaptability test according the Manufacturing and Testing Trial Procedures. The results showed that the identification results of BHK-21 cells from F11 to F52 generations were in line with the regulation requirements. To ensure the stability of cell seeds, it is recommended that vaccine production be limited to 43 generations of cells.
作者
李建华
张智明
何世岷
窦海燕
方超
刘旭
LI Jianhua;ZHANG Zhiming;HE Shimin;DOU Haiyan;FANG Chao;LIU Xu(Harbin Pharmaceutical Group Bio-vaaccine Co.,Ltd.,Harbin 150069,China)
出处
《饲料博览》
2020年第8期6-9,共4页
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