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目的分析由卡介菌上海D2株工作种子批连续传代至不同代次的菌种制备的疫苗的质量差异。方法选取自工作种子批(11-007)传代至6、9、12代的单批培养物制备的皮内注射用卡介苗,采用多重PCR法鉴定特异性缺失区RD1;对原液的单位产能、半成品的沉降率、成品的效力及热稳定性进行测定,并对结果进行统计学分析。结果6、9、12代菌种培养物制备的卡介苗成品缺失RD1区,具有卡介菌特征;各代次制备的疫苗单位产能、沉降率、动物效力、热稳定性检测结果差异均无统计学意义(P>0.05),且疫苗动物效力、热稳定性检测结果均符合《中国药典》三部(2010)版及国家药监局批准的企业注册标准。结论工作种子批连续传代至不同代次的卡介菌制备的皮内注射用卡介苗均缺失RD1区,具有卡介菌的特征,关键质量指标安全、有效、一致。
OBJECTIVE: To analyze the quality differences of vaccines prepared by continuous fermentation of Bacillus Calmette-Guerin-Shanghai D2 seed strains in different generations. Methods Single intradermal inoculation BCG vaccine was prepared from single-batch cultures of working seed batch (11-007) passaged to 6, 9 and 12 generations. The specific deletion region RD1 was identified by multiplex PCR. The sedimentation rate of semi-finished products, the effectiveness of finished products and thermal stability were measured, and the results were statistically analyzed. Results The products of 6, 9 and 12 generations of BCG vaccine were lacking RD1 region and had the characteristics of BCG. The vaccine unit production capacity, sedimentation rate, animal efficacy and thermal stability test results were not statistically different (P> 0.05), and the test results of the efficacy and the thermal stability of the vaccine animals all met the registration standards of “Chinese Pharmacopoeia” (2010) and the SFDA approved business registration. CONCLUSION: The intradermal BCG vaccines prepared by continuous passage of working seed batches to different generations of Bacillus Calmette-Guerin all lack the RD1 region, which has the characteristics of BCG. The key quality indicators are safe, effective and consistent.