Development of a reference substance for live bacterial count of Streptococcicosis live vaccines.

Lingxiang Xin; Xiuli Wang; Wenjing LV; Lianna Zang; Dongmei Zhu; Ying Luo; Yuan Zhang; Xiaoning LI; Bo Liu; Junping LI

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Development of a reference substance for live bacterial count of Streptococcicosis live vaccines.

Author: Lingxiang XIN ¹ ; Xiuli WANG ¹ ; Wenjing LV ² ; Lianna ZANG ² ; Dongmei ZHU ³ ; Ying LUO ³ ; Yuan ZHANG ¹ ; Xiaoning LI ¹ ; Bo LIU ¹ ; Junping LI ¹
Author Information

1. China Institute of Veterinary Drug Control, Beijing 100081, China.
2. Tianjin Ringpu Bio-technology Co., Ltd. Airport Business Park Branch Company, Tianjin 300300, China.
3. Huapai Bioengineering Group Co., Ltd., Jianyang 641400, Sichuan, China.
Publication Type:Journal Article
Keywords: Streptococcus; collaborative calibration; live bacterial count; reference substance
MeSH: Bacterial Load; Reference Standards; Vaccines, Attenuated
From: Chinese Journal of Biotechnology 2021;37(7):2554-2562
CountryChina
Language:Chinese
Abstract: This study attempts to develop a reference substance for the live bacteria count of Streptococcicosis live vaccines in order to evaluate the validity of live bacterial count in inspection and testing. We prepared a batch of live Streptococcus suis reference substance for live bacterial count, tested their physical property, purity, vacuum degree, remaining moisture, and determined their homogeneity, thermal stability and transportation stability. Moreover, we organized collaborative calibration to assign count values to the reference substance and determine the shelf life of the reference substance in 12 months. The results showed that the physical property, the purity, the remaining moisture and the vacuum degree of the reference substance were all in compliance with the requirements of the Chinese Veterinary Pharmacopoeia. The homogeneity test showed that the coefficient of variation of the count of the reference substance was less than 10%, indicating a good homogeneity. Transportation stability test showed that the reference substance remained active after 72 h transportation in summer and winter with the package of styrofoam boxes and ice packs. Thermal stability test showed that the reference substance could be stored for up to 3 months at -20 °C, or up to 21 days at 4 °C. According to the collaborative calibration, the reference vaccine was assigned a count value range of (8.5-12.1)×107 CFU/ampoule. The shelf life test showed that the reference substance was stable for 12 months when stored at -70 °C. The reference substance could provide a reference for the live bacterial count of Streptococcicosis live vaccines. Moreover, it could also be used as a reference to evaluate the quality of corresponding agar media.