Efficient manufacturing system needed to lower cost of Monoclonal antibody therapy, says former ICMR DG Nirmal Ganguly

By Joymala Bagchi
New Delhi [India], May 30 : The cost of Monoclonal antibody therapy, which was recently approved by India's top drug regulatory body for treatment of COVID-19, can be lowered if a very efficient system for its manufacturing is developed, said Dr Nirmal K Ganguly, former Director-General of the Indian Council of Medical Research (ICMR) on Sunday.
"Nowadays monoclonal antibodies are produced through Mammalian cell culture system and can be produced in a larger amount through fermentation technology," the former ICMR DG told ANI.
"This Mammalian cell culture system has to be a very high expression system because it is being given in grams and not in milligrams or in micrograms for which the amount required has to be produced very efficiently and that makes it costly," Dr Ganguly added.
Speaking further, she said: "The price can be brought down if one can make a very efficient system. Manufacturing and skill in production is a very important part of the whole process."
These antibodies are lab-made and are specifically tailored to fight the disease they treat, however, the price of administering this antibody remains out of reach for many people. The artificial process through which monoclonal antibodies is a fermentation process in which one produces few vials.
"Both the antibodies have to be used as single antibody induced mutations. Regeneron has produced new antibodies targeting mutant. Countries will be able to do match and mixing. Cipla is marketing it in partnership with Roche with future option to manufacture," observed Dr. Ganguly.
Citing ineffectiveness in the number of new cases as per the guidelines of the ICMR, he also supported the dropping use of convalescent plasma theory from the recommended treatment protocols for COVID-19.
"These antibodies have to be used early because once the virus enters the cell these antibodies fail to do much. They don't enter the cell but work when the virus is attempting to enter the cell," the expert said.
"Since this is a highly expensive product, it should not be used for all COVID-infected individuals. Use it only for those with severe infections, those who have been hospitalised with high chances of mortality, and patients with severe comorbidities like liver diseases, cardiovascular diseases, etc," Dr Ganguly said.
The first person to be administered the antibody therapy was an 84-year old male Covid-positive patient in Gurgaon who went back to his home on May 27. He has become the first person in India to be administered the COVID drug cocktail, which came into the limelight after it was administered to former US President Donald Trump when he tested positive for the virus last year.
The antibody cocktail therapy is not recommended for patients who are hospitalized due to severe COVID-19, or those who require oxygen therapy due to COVID-19 or who require an increase in baseline oxygen flow rate due to the disease and in patients on chronic oxygen therapy due to underlying non-Covid-19 related comorbidity.
This FDA-approved therapy demonstrated good efficacy in Phase 1/2 and Phase 3 studies by reducing COVID-19 related hospitalization and death by 70 per cent. Approved by the Drugs Controller General of India (DCGI), this single dose infusion-based treatment can be provided on an outpatient or day care basis and marks a dramatic shift in coronavirus care in India.