Covaxin batches rejected due to stability issues caused disruption in July supply

1 month ago 29
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NEW DELHI: Covaxin supplies were disrupted in July as initial batches from Bharat Biotech’s new fermentation plant at Bengaluru faced some stability issues and were rejected for supply. The batches were not utilised. Stability studies on vaccines and various other pharmaceutical products are conducted to determine the storage period of intermediates and determine or modify the maximum shelf-life. Experts say it is a regular phenomenon when batches of drugs and vaccines fail to qualify stability test.
According to the source, disruption at Bharat Biotech’s plant assumed significance because it resulted in a slowdown in vaccination. However, there is no quality issue with the vaccine as such. “It is a new facility with large-scale fermentation plant. The trial batches were disrupted during standardisation process and therefore, the supply of Covaxin was less than expected. It has been sorted out now and supplies have also started. It will be full-scale very soon,” the official said.

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