鹅细小病毒灭活疫苗种子批建立

The Seed Lots Built of Goose Parvovirus Inactivated Vaccine Candidate

关键词:  种子批建立、YA98株、培养特性、特异性

Key words:  seed  batch build, strain  YA98, culture  characteristics, specificity

摘要:

为了保证制苗所用毒种质量和稳定性，在对制苗毒种病毒含量、病毒纯净性、特异性、免疫原性及扩繁代次等研究的基础上，建立了鹅细小病毒灭活疫苗毒种种子批。试验使用鹅胚对鹅细小病毒YA98株进行了20次传代。对传代毒种的鉴定结果表明：抽检的各代次的毒种均无细菌、支原体、外源病毒污染，且病毒含量检测稳定，每0.3 mL 含104.78～4.85 ELD50 ；各代次特异性检测均能被鹅细小病毒抗血清中和；将各代次病毒液制成灭活疫苗，免疫成鹅后均能产生完全保护。以此为依据，最终确定原始毒种和基础毒种的扩繁代次宜控制在5代以内，生产毒种的最高扩繁代次宜控制在15代以内。种子批的建立，为鹅细小病毒灭活疫苗的生产奠定了基础。

Abstract:

IAbstract: In order to ensure vaccine-made virus seed quality and stability, we established a goose parvovirus inactivated vaccine virus seed lot, on the research basis of vaccine-made virus seed virus content, virus pure, specific, immunogenicity and expanding propagation generations. The goose parvovirus YA98 strain was propagated and passaged 20 generations on goose embryo. Passage of virus identification results show that there were not found bacteria, mycoplasma, contamination with exogenous virus in sampling of each propagation generations virus; and virus content test was stable, per 0.3ml containing 104.78-4.85 ELD50; and it can be neutralized by goose parvovirus antiserum in specific detection; when it was made inactivated vaccine to inject geese, they could produce complete protection. On this basis, we ultimately determined that the propagation generations of the original virus and virus should be controlled within 5 ones and the highest propagation generation of production virus should be controlled within 15 ones. The establishment of the seed lot laid the foundation for the goose parvovirus inactivated vaccine production.