Both European Pharmacopoeia Monograph 01/2008:0447 "Canine Leptospirosis vaccine (inactivated)" and the more recent Monograph 01/2008:1939 "Bovine Leptospirosis vaccine (inactivated)" explicitly allow for a sero-response test to assess batch potency. Test setup and requirements for in vivo and in vitro validation are described. Furthermore, the two main strategies to assess batch potency and th...

Advancements in Case Studies Quantum microRNA Assessment of COVID-19 RNA Vaccine: Hidden Potency BNT162b2 SASR-CoV-2 Spike as MicroRNA Vaccine Fujii YR* Kawada-Cho, 106-6, Atsuta-Ku, Nagoya, Japan *Corresponding author: Yoichi Robertus Fujii, Submission: March 05, 2021;Published: 16, 2021 DOI: 10.31031/AICS.2021.03.000552 ISSN 2639-0531Volume3 Issue1

Vero cells used by distinct measles vaccine control laboratories had their susceptibility to Moraten, Schwarz and Biken CAM-70 vaccine strains assayed. Of a total of 72 lots of measles vaccine whose potency was titrated by microtechnique in two Vero cell samples (Vero IB and Vero INCQS), 25 had been produced with Moraten strain, 24 with Schwarz and 23 with Biken CAM-70. The statistical analysis...

A 10% suckling rat brain rabies vaccine free from encephalitogenic activity was prepared and inactivated with 1:8,000 beta-propiolactone (BPL), or ultraviolet light, or a combination of ultraviolet light and BPL, or 1% phenol. Potency was excellent in all samples, with the exception of the phenolized product which was marginal. A purified suckling rat brain (SRB) vaccine prepared by zonal centr...

The potency of inactivated Newcastle disease virus (NDV) vaccines in the United States is currently determined using vaccination and challenge of experimental animals against a velogenic strain of NDV. Because velogenic strains of NDV are now classified as select agents in the United States, all vaccine potency testing must be performed in live animals under biosafety level 3 agriculture condit...

Introduction Vaccine manufacturers evaluate the efficiency of their vaccine according to the method which is defined in the European Pharmacopoeia. Regarding foot-and-mouth disease (FMD) vaccine there are some difficulties to find animals for potency tests in the countries like Turkey where FMD is endemic and vaccine campaigns are carried out. In addition, potency tests must be carried out in c...