Bharat Immunologicals and Biologicals Corporation Ltd., Village: Chola, Bulandshahr, India.
Abstracts of the papers presented at the International Conference of Indian Virological Society on “Emerging and Re-emerging viral Diseases of the Tropics and Subtropics” at Indian Agricultural Research Institute, New Delhi, India, December 11–14, 2007.
The study was done with the objective to measure, monitor, and document the potency of oral polio vaccine for a period of 30 months at 4°C and –20°C. Three representative samples from eight different batches have been taken for potency by tissue culture technique. The estimation of composite virus content was done by microtitration using Hep 2 (Cincinnati) cells, obtained from Central Drug Laboratory, Kasuali, H.P., with the standard procedure. The minimum virus content to pass the potency test per one human dose of the vaccine was log10 (6.00) for Type 1, log10 (5.03) for Type 2, log10 (5.82) for Type 3 and log10 (6.25) for trivalent oral polio vaccine. There was no more loss in potency as per acceptance limit till 30 months of study. Adequate potency of vaccines tested in this study confirms the ideal virus titre at the time of manufacturing and ideal storage conditions. But there is need of testing in field samples to check the transport conditions and vaccine vial monitor (VVM) status. The use of potency control testing is a valuable tool for testing the actual relative strength of manufactured assembly lots of vaccine. Biological-based manufacturing methods are inherently variable and potency testing is a tool to ensure lot-to-lot consistency of commercial vaccines. Sterility of the same samples has been checked by filtration method.
