Total combining power: Technique for the evaluation of the quality control process of clostridiosis vaccines

An efficient technique for evaluation of the quality control of vaccines against clostridiosis is described in this study. This technique is capable of quantifying the toxoid of the bacterium Clostridium perfringens Type D, which is commonly found within these vaccines. The described method is perfo...

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Bibliographic Details
Published in:	Journal of microbiological methods Vol. 130; pp. 164 - 168
Main Authors:	Brandi, Igor Viana, Santos, Eliane Macedo Sobrinho, Carvalho, Bruna Mara Aparecida de, Durães, Carla Adriana Ferreira, Farias, Paula Karoline Soares, Sari, Roger Shoji, Cangussu, Alex Sander Rodrigues, Pessoa, Adalberto
Format:	Journal Article
Language:	English
Published:	Netherlands Elsevier B.V 01-11-2016
Subjects:	Animals Antibodies, Bacterial - blood Antibodies, Bacterial - immunology Bacterial Toxins - immunology Bacterial Vaccines - immunology Bacterial Vaccines - standards Bacterial Vaccines - toxicity Clostridiosis Clostridium Infections - immunology Clostridium Infections - prevention & control Clostridium perfringens Clostridium perfringens - immunology Clostridium perfringens - pathogenicity Female Mice Models, Animal Neutralization Tests - methods Quality Control Reproducibility of Results Sensitivity and Specificity Total combining power Toxin and toxoid Vaccine Vaccines, Inactivated Validation Validation L+ dose Total combining power Standard epsilon antitoxin Epsilon toxoid International antitoxin unit (I.U.) Vaccine Toxin and toxoid Clostridiosis Lo dose Standard epsilon toxin
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Summary:	An efficient technique for evaluation of the quality control of vaccines against clostridiosis is described in this study. This technique is capable of quantifying the toxoid of the bacterium Clostridium perfringens Type D, which is commonly found within these vaccines. The described method is performed in vivo to quantify the toxoid, replacing the current predominant approaches that use the titration of toxins before the inactivation process. This method is based on the partial neutralization of a determined dose of antitoxin by testing different doses of the toxoid. In order to guarantee its reliability, it is essential for the technique to be validated. Thus, the technique was tested using the following validation parameters: specificity and selectivity, detection limit, linear correlation, precision and robustness, in agreement with the requirements of regulatory agencies and international committees from around the world. The method was found to be specific, selective, robust, precise, and linear inside a specific concentration range. Therefore, it could be applied to the quality control of clostridiosis vaccines with satisfactory results. •Total combining power (TCP) allows accurate measurement of toxoid concentration.•TCP can control the process of development and production of toxoid-based vaccines.•Suitable TCP values ensure production of antibodies in vaccinated animals.•Use of TCP for process control is more efficient compared to LD50 and L+.•TCP is specific, selective, and applicable to process control in vaccine production.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23
ISSN:	0167-7012 1872-8359
DOI:	10.1016/j.mimet.2016.08.023