title: Total combining power: Technique for the evaluation of the quality control process of clostridiosis vaccines.
abstract: 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.
authors: Universidade Federal de Minas Gerais - UFMG, Av. Universitária, 1000, Bairro Universitário, Montes Claros, MG 39404-547, Brazil. Electronic address: ibrandi@hotmail.com.
authors: Igor Viana
authors: IV
authors: Brandi
authors: Instituto Federal do Norte de Minas Gerais - IFNMG, Fazenda do Meio Pé da Serra, S/N, BR367, Km 278, Araçuaí, MG 39600-000, Brazil.
authors: Eliane Macedo Sobrinho
authors: EM
authors: Santos
authors: Universidade Federal de Minas Gerais - UFMG, Av. Universitária, 1000, Bairro Universitário, Montes Claros, MG 39404-547, Brazil.
authors: Bruna Mara Aparecida de
authors: BM
authors: Carvalho
authors: Universidade Federal de Minas Gerais - UFMG, Av. Universitária, 1000, Bairro Universitário, Montes Claros, MG 39404-547, Brazil.
authors: Carla Adriana Ferreira
authors: CA
authors: Durães
authors: Universidade Federal de Minas Gerais - UFMG, Av. Universitária, 1000, Bairro Universitário, Montes Claros, MG 39404-547, Brazil.
authors: Paula Karoline Soares
authors: PK
authors: Farias
authors: Universidade Federal de Minas Gerais - UFMG, Av. Universitária, 1000, Bairro Universitário, Montes Claros, MG 39404-547, Brazil.
authors: Roger Shoji
authors: RS
authors: Sari
authors: Universidade Federal do Tocantins - UFT, Zona Rural, Gurupi, TO 77402-970, Brazil.
authors: Alex Sander Rodrigues
authors: AS
authors: Cangussu
authors: Universidade de São Paulo - USP, Av. Professor Lineu Prestes, 580, Bloco 16, Butantan, São Paulo, SP 05508-000, Brazil.
authors: Adalberto
authors: A
authors: Pessoa
mesh_terms: D000818:Animals; D000907:Antibodies, Bacterial / Q000097:blood / Q000276:immunology; D001427:Bacterial Toxins / Q000276:immunology; D001428:Bacterial Vaccines / Q000276:immunology* / Q000592:standards* / Q000633:toxicity; D003015:Clostridium Infections / Q000276:immunology* / Q000517:prevention & control; D003016:Clostridium perfringens / Q000276:immunology* / Q000472:pathogenicity; D005260:Female; D051379:Mice; D023421:Models, Animal; D009500:Neutralization Tests / Q000379:methods; D011786:Quality Control; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D015164:Vaccines, Inactivated
chemical_list: D000907:Antibodies, Bacterial; D001427:Bacterial Toxins; D001428:Bacterial Vaccines; C039811:Clostridium perfringens epsilon-toxin; D015164:Vaccines, Inactivated
keywords: Clostridiosis; Total combining power; Toxin and toxoid; Vaccine; Validation