In Process Quality Control Factors Affecting Potency of Foot and Mouth Disease Virus Vaccine (Clinical Report‪)‬

Byline: Khushi Muhammad, Zafar Iqbal Chaudhry, Masood Rabbani, Imran Altaf, Munir Ahmad Tariq and Muhammad Anees Abstract.- In process quality control factors affecting potency of Foot and Mouth Disease (FMD) virus vaccine were evaluated. These factors were amount of immunogen (biological titer of FMD "O" virus), inactivants, safety and sterility tests, adjuvant and keeping quality of the vaccine. The biological titer of 7th passage of the serotype on BHK-21 cell line was 106.4 mean tissue culture infective dose (TCID50) per ml. The dose of immunogen was directly proportional to complement fixing antibody titer in rabbits. The virus in the suspension culture was inactivated at 37degC with 0.12 percent formaldehyde for 12 hours or 0.02 M binary ethylene-imine (BEI) for 48 hours. The sterility of the virus suspension was determined by inoculating the culture on laboratory bacteriological media and safety was monitored on monolayer of BHK-21 cell line. The virus serotype suspension culture qualified for vaccine production.