In process quality control factors affecting potency of foot and mouth disease virus vaccine

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 biologica...

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Published in:Pakistan journal of zoology 2011-04, Vol.43 (2), p.249-254
Main Authors: Muhammad, K. (University of Veterinary and Animal Sciences, Lahore (Pakistan). Dept. of Microbiology), Chaudhry, Z.I. (University of Veterinary and Animal Sciences, Lahore (Pakistan). Dept. of Pathology), Rabbani, M. (University of Veterinary and Animal Sciences, Lahore (Pakistan). Univ. of Diagnostic Lab.), Altaf, I, Tariq, M.A, Anees, M
Format: Article
Language:English
Subjects:
Chemical properties
Control
FOOT AND MOUTH DISEASE
Foot-and-mouth disease virus
IMMUNE RESPONSE
IMMUNIZATION
KEEPING QUALITY
LIVESTOCK
PAKISTAN
PROCESSING QUALITY
Product development
QUALITY CONTROLS
RABBITS
VACCINES
Viral vaccines
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Summary: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 10(6.4) 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 37 degree C with 0.12 percent formaldehyde for 12 hours or 0.02 M binary ethylene-imines (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. The effect of aluminum hydroxide gel (AHG) and oil base-montanide (OB) in inducing the antibody response in rabbits was the same. Antibody response of rabbits to both of the adjuvant containing vaccines was better than that of lanolin based vaccine. The storage of the vaccine at 6 (plus minus 2) degree C for 6 months did not affect its potency in rabbits. It is concluded that amount of the virus immunogen in the vaccine is directly proportional to the titer of antibody response in vaccinates.
ISSN:0030-9923