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Biological E Ltd and the Indian Council of Medical Research have developed a highly purified antisera, which is raised in horses, for prophylaxis and treatment of infectious diseases, with potential to treat Covid-19.
Within few months, Biological E, which has been working with the National Institute of Virology, Pune, that is part of ICMR, has managed to develop this and will soon begin trials and possibly larger supplies within months after receiving approvals. This will be a totally indigenous effort.
Vikram Paradkar, Senior Vice-President and Head, Technical Operations, Biological E, told BusinessLine , “Equine anti-sera products, also termed as highly purified enzyme processed equine immunoglobulins, are in use for more than 100 years to treat various infections such as tetanus, diptheria, rabies and injury caused by snake and scorpion bites.”
“National Institute of Virology, Pune, a division of ICMR, isolated the SARS-CoV-2 virus that causes Covid-19 and developed a process to grow and then inactivate this virus by gamma-irradiation under controlled conditions. Biological E then entered into a collaboration with NIV-ICMR to develop the antisera product using the inactivated SARS-CoV-2 virus from NIV,” he said.
Biological E combined the inactivated virus with specific adjuvants to develop an immunisation protocol for horses, and the sera collected, post-immunisation, was tested at NIV-Pune. It showed significant concentration of antibodies that could not only recognise the SARS-CoV-2 virus but also neutralise it in the lab study.
‘Therapy to benefit patients’
The vaccine-maker then developed a manufacturing process to isolate, purify and formulate the equine antibodies in a highly consistent formulation. These batches, which were then tested at NIV-Pune, confirmed the presence of neutralising antibodies in high concentration. Biological E has now completed various characterisation and animal toxicity studies to confirm suitability of this product for clinical trials in hospitalised Covid-19 patients suffering moderate symptoms.
“These clinical trials are expected to begin soon and will help identify the safe and efficacious dose of the product and the nature of patients that will benefit the most from this therapy,” he explained.
“Now we are able to start clinical trails. Will administer the dose to people with moderately infected patients and see if it can slow down the progress of the disease. It is like convalescent therapy, where we take plasma from people who are affected and recover. However, the problem is each person is different, therefore cannot have a standardised treatment. Therefore, we are looking at this approach,” he explained.
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