Potency testing of veterinary vaccines: The way from in vivo to in vitro

Regulatory acceptance and use of serology for inactivated veterinary rabies vaccines

“…However, it has a number of weaknesses. First, the test parameters differ from the natural situation, e.g., the intracranial challenge route does not reflect the natural route of infection nor does the intraperitoneal vaccination reflect the normal route of immunization (Romberg et al, 2012;Wunderli et al, 2006), and test results show high variability of up to 400% (Bruckner et al, 2003;Krämer et al, 2009). These drawbacks of the NIH test have made rabies vaccine potency testing a high priority in terms of the 3Rs, i.e., models to replace, reduce or refine the conventional animal model (Russell and Burch, 1959).…”

Preparation of purified vaccine from local isolate of foot and mouth disease virus and its immune response in bovine calves

“…Potency testing of vaccine is an expensive matter based on protection in vivo such as toxin-neutralization, immunization-challenging or immunization-serological tests. Scientific consideration and animal welfare concerns have established 3R-concept discouraging extensive use of animals in challenging phase which causes distress, pain and supporting use of alternative serological tests for assuring vaccine potency ( Romberg et al, 2012 ). Several researchers have developed alternative approaches by using live animals and in-vitro models to find correlation between 146S content load in vaccine and protection elicited ( Alkan et al, 2008 ).…”

Leptospira and Leptospirosis

“…Welfare legislation and ethical review processes in many countries discourage these uses and alternative methods of vaccine potency testing are being developed (Klaasen et al 2013;Stokes et al 2012;Romberg et al 2012). They have also been used in the indirect isolation of leptospires, as a means of recovering leptospires from contaminated environments, passaging leptospires to enhance virulence and in vaccine potency testing.…”