Bharat Serums working on polyclonal antibody product for Covid-19 treatment

The company has invested Rs 100 cr in manufacturing capex in the last one year

Mumbai-based biotech firm Bharat Serums and Vaccines (BSVL), is working on developing an in-house polyclonal antibody product for the treatment of Covid-19. If the trials are successful it would be the first such indigenously developed polyclonal antibodies product in India.

Speaking to Business Standard, Sanjiv Navangul, MD and CEO of BSVL, said that the spike protein of Sars-CoV-2 is used to develop antibody titers which are then extracted and purified to create the product. “We have done some neutralisation trials in the laboratory in India, and some studies in the US as well. We got excellent results,” Navangul said. Human clinical trials are yet to begin here.

Our bodies create proteins called antibodies to fight infections. Monoclonal antibodies are artificial antibodies that mimic the activity of our immune system. They are laboratory produced through a process of extraction of antibodies from human blood or serum and then cloning them. These are highly purified and concentrated forms of antibodies which are now actively used in Covid-19 treatment.

In contrast, polyclonal antibodies are made using different immune cells. They will have affinity for the same antigen, but different parts (epitopes) of the antigen molecule to which an antibody attaches itself. Monoclonal antibodies are made using identical immune cells that are clones of a specific parent cell.

Players like Roche have made an antibody cocktail therapy available in India. British drug major GlaxoSmithKline (GSK) recently got the US drug regulator's nod for its monoclonal antibody (Sotrovimab) for treating mild to moderate Covid-19 patients above 12 years. Ahmedabad-based Zydus Cadila has sought permission from the Drugs Controller General of India (DCGI) for initiating clinical trials for its antibody cocktail – ZRC-3308. For now, Zydus is the only Indian company to have developed a neutralizing monoclonal antibody based cocktail for the treatment of Covid-19.

BSVL’s product, a polyclonal antibody, will be the first indigenously developed one if it proves successful in human trials eventually.

Navangul felt that since the virus has a tendency to mutate, theoretically, a polyclonal antibody can be a better bet. This, however, has to be studied, he added. If a Covid-19 patient is given such a product (one or two shots) within the first five days or so, one neutralises the virus and has a better chance at recovering fast, he claimed.

Navangul said that since their product would be developed and manufactured in India, the prices could be more affordable than global products. Cipla has launched Roche’s antibody cocktail product at Rs 59,750 a patient in June.

Apart from this, BSVL is researching the clotting and inflammation caused by Sars-CoV-2 infection and products that may address these. “We are studying the factors and understand where if we intervene, we can have an impact on the clotting mechanism. Similarly, we are looking for markers of inflammation. We are working on some products which have shown some promise. We will try to do some work in clinical settings also now,” he explained.

Doctors have found use of antibody therapy useful in Covid patients. In a recent conference, Randeep Guleria, director, All India Institute of Medical Sciences (AIIMS), New Delhi said that monoclonal antibodies have proved useful for patients with high risk of severe disease but more data is needed on its efficacy.

BSVL has posted a 45-50 per cent growth in turnover last fiscal. The Advent PE backed firm has drawn around 20-25 per cent of its turnover from Covid19 in the first half of this year, and expects this to go down to 10 per cent of revenues eventually. The non-Covid-19 business has grown by 25-30 per cent last fiscal. Navangul did not divulge the revenue figures.