流产布鲁菌病疫苗候选株种子批的研究

Establishment of the seed batches of B.abortus vaccine candidate RB6

将流产布鲁菌病疫苗候选株RB6原始菌种,经体外连续传20代,取其第3、5、10代培养物分别检测培养特性、细菌含量、纯净度、变异、毒力和免疫效力,合格产物加入冻干保护剂定量分装冻存管冻干保存,批号分别定为2010RB6F3、2010RB6F5、2010RB6F10;取第13、14、15、20代培养物做上述指标检测,检验合格后加入冻干保护剂定量分装20mL西林瓶、冻干保存,批号分别定为2010RB6F13、2010RB6F14、2010RB6F15。根据对各批次的检测结果和种子批的建立原则,最终确定了第3、5、10代冻干品可作为基础种子批,第13、14、15代冻干品可作为生产种子批。

The brucellosis vaccine candidate RB6 was in vitro passaged for 20 generations. The cultures of 3th, 5th, and 10th generations were respectively tested for the growth characteristics, the number of viable bacterium, purity, variability in vitro, their virulence, and protective efficacy in mice. Then the cultures were mixed with the cryoprotectant, and subpackaged, tyophilized, which were referred to as the batch No.2010RB6F3,2010RB6FS, and 2010RB6F10, respectively. The 13th, 14th, 15th, and 20th generations were also tested for the above mentioned similar items and mixed with the cryoprotectant, and subpackaged into 20 ml bottles, lyophilized, which were referred to as Batch No. 2010RB6F13,2010RB6F14, and 2010RB6F15, respectively. Based on our testing results and the seed batch requirement, 2010RB6F3,2010RB6FS, and 2010RB6F10 were determined as the basal seed batches, while 2010RB6F13, 2010RB6F14, and 2010RB6F15 as the production seed batches.