摘要
根据GMP要求以及表达乙肝表面抗原(HBsAg)的重组酿酒酵母Saccharomyces cereviae2150-2-3(PHBS56-GAP347/33)[2]培养工艺要求,设计基因工程疫苗生产用微生物反应器A型罐和B型罐的热分布验证试验方法,分别对它们进行验证,通过热分布试验验证其灭菌温度均匀性。
Based on the requirements of GMP and culture process for HBsAg in Saccharomyces cereviae2150-2-3, the test methods of verifying heat distribution in microbe reactor A and reactor B used in vaccine production were designed. Then, the homogeneity of heat distribution in two reactors was verified.
出处
《医药工程设计》
2008年第1期32-36,共5页
Pharmaceutical Engineering Design
关键词
微生物反应器
热分布验证
设计
microbe reactor
verification of heat distribution
design
