Quality Control Testing of the Clostridial Vaccine, Advantages and Challenges a Comprehensive Review

Clostridium perfringens causes severe damage in the gastrointestinal tract of ruminants and birds leading to death. So, C. perfringens infection can influence livestock and poultry industry, especially fat animals. Vaccination can highlight and improve animal health by preventing the clostridial disease. The quality control of veterinary vaccines mentioned by regulatory agencies are described in their guidelines. Each batch of these biological products is subjected to multiple testing and must meet a series of requirements, including sterility, safety, purity, and potency. Clostridial exotoxins, especially major exotoxins, are the main virulence factor of the clostridial vaccine; therefore, determination of the biological activity in each batch series of vaccine is necessary. There are two categories of efficacy tests (in vitro and in vivo) that are performed during the vaccine manufacturing, and on the final product. This comprehensive study reviews briefly the QC methods for determination of the biological activity, advantages, challenges, and possible problems associated with quality control testing of each veterinary C. perfringens vaccine. In spite of different sensitivity, specifity, and accuracy, the quality control of vaccine should be well done in accordance with pharmacopoeial monographs or other references in order to gain reliable results.