Sayak Banerjee, Amity University Kolkata
Out of all the vaccine-making companies, Bharat Biotech is the only one to locally develop a vaccine in India and result in large-scale manufacturing. The manufacturing of Covaxin had been started at Ankleshwar, Gujarat before which equipment efficacy was studied by carrying out engineering batches. After a 120-day timeline for manufacturing, testing, release, regulatory approvals, and distribution, supplies were available during September.
It has been said that every batch of Covaxin is submitted to more than 200 quality control tests at its different facilities. This is followed by sending the samples to the Central Drugs Laboratory (CDL) and the batches are discharged commercially only upon the approval by the Lab at Genome Valley. The manufactured vaccines are not released until they are fully audited and authorized by the regulatory authorities. Bharat Biotech has accomplished this in around 15 months, along with 10 scientific publications on vaccine trials.
Recently, Bharat Biotech has earned a certificate of Good Manufacturing Practice (GMP) agreement for the COVID-19 vaccine Covaxin from the authorities of Hungary. This advancement will increase opportunities for the European market for the indigenously developed vaccine. They mentioned that GMP for the manufacture of Covaxin got approved by the National Institute of Pharmacy and Nutrition, Hungary. The database of the European Community of manufacturing authorizations and certificates of good manufacturing practice (EudraGDMP database) has now listed the certificate of GMP received by Bharat Biotech. This symbolizes the first EudraGDMP compliance certificate achieved by the Hyderabad-based vaccine makers from the European authorities, listed in their collection of records.
The vaccine manufacturers are set towards submitting documentation for Emergency Use Authorization (EUA) in many other countries worldwide. To date, the vaccine has obtained EUA from almost 16 countries. Manufacturing and innovation of vaccines at global quality standards have made Bharat Biotech attain another noteworthy milestone. This recognition on an international level will enhance their commitment towards becoming an international company by improving their research and development of vaccines in the ongoing fight against COVID-19.
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Reference:
Aug 6, S. B. / T. /, 2021, & Ist, 04:55. (n.d.). Covaxin bags gmp cert from hungary | hyderabad news—Times of india. The Times of India. Retrieved August 7, 2021. https://timesofindia.indiatimes.com/city/hyderabad/covaxin-bags-gmp-cert-from-hungary/articleshow/85081061.cms
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About Author:
Sayak Banerjee is a 3rd year Biotechnology Engineering Student with great interest in Immunology and Molecular genetics. He is a creative scientific writer in Bioxone with an inclination towards gaining knowledge regarding vast sections of Biotechnology and emphasizing himself in various wet lab skills.
Publications:
- https://bioxone.in/news/worldnews/car-t-cells-scientists-discover-on-off-switches-for-cell-immunotherapy/
- https://bioxone.in/news/worldnews/neutrophil-derived-nanovesicles-a-novel-drug-delivery-system/
- https://bioxone.in/news/worldnews/pig-to-human-heart-transplantation-a-solution-to-the-rarity-of-donor-organs/
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