Covid-19 fight: Indian companies join race to develop blood products

Ahmedabad-based Intas Pharma’s Plasma Division and Mumbai-headquartered Bharat Serums and Vaccines (BSVL) are looking to produce what are commonly known as hyperimmune globlulins
Covid-19 has already claimed about a million lives globally and the toll is rising. As the development of vaccines or any drug will take time, research on Sars-CoV-2 neutralising antibodies is gaining ground to fill an unmet demand in therapy.

 
Global majors like Roche and Takeda are working on antibody therapies, and Indian firms aren’t far behind. Ahmedabad-based Intas Pharma’s Plasma Division and Mumbai-headquartered Bharat Serums and Vaccines (BSVL) are looking to produce what are commonly known as hyperimmune globlulins from convalescent plasma from recovered patients and horses.

 
What are hyperimmune globulins?

 
A patient who has recovered from Covid-19 has antibodies that are targeted against the virus. In convalescent plasma therapy, these antibodies are administered to a patient. The problem with this approach is that the amount of antibodies differs from one donor to another and plasma has to be stored at very low temperatures. An elaborate infrastructure is needed to get and process plasma at the centre. Complicating things further, the blood groups of the donor and recipient have to match.

 
Covid-19 hyperimmune globulin is also prepared from convalescent plasma. It is processed, purified and concentrated, and blood borne pathogens are removed, and made into standard doses. Intas, for example, is making 10 ml vials.

 
A patient typically needs 30-60 ml dosage, as compared to 200-400 ml of plasma. Further, handling and administration is easier as it can be stored at temperatures of 2-8 degree Celsius.

 
An Intas spokesperson said the company is conducting phase 2 clinical trials. After this, it might approach the Drug Controller General of India (DCGI) to seek emergency use authorisation as there is an unmet need for these products. The target group would be moderate to severe patients, and it might help protect them from progressing to the critical stage.

 
Mumbai-based BSVL has adapted its plasma fractionation platform technology to produce equine polyclonal antibody product against Sars-CoV-2.

 
Sanjiv Navangul, the firm’s managing director and chief executive officer, said using horses for convalescent plasma is useful as one can build the antibody titres very fast. “We used antigens on horses and the antibody titres came out very well. The in vitro studies show good results.”

 
Horses are injected with the antigen and then the plasma is extracted. This process is well established and has been in use for years.

 
BSVL has held discussing on the product with the Indian Council of Medical Research (ICMR). Navangul said ICMR is willing to provide antigens for BSVL’s product.

 
This might take time as institutions like the National Institute of Virology (NIV) are overwhelmed with work. “Meanwhile, we acquired a few antigens through DCGI approval and have started work,” he added. BSVL is now testing the safety and efficacy of its product and is working in US laboratories. “It is now faster to test outside as our Indian laboratories are already quite overburdened. If we use the ICMR antigen, then we may test the product at NIV. BSVL has not yet started human trials,” Navangul said.

 
Dr Jaby Jacob, head of research and development at BSVL, said: “We have now developed enough plasma from horses from which we have extracted the antibodies. We are now checking the binding of the antibody to the spike protein of the virus. In vitro studies have shown that the antibody is successfully binding itself. Next, we will test to see if the virus gets neutralised.”

 
What about the product’s pricing?

 
While firms did not wish to comment on pricing as the products are under development, industry sources said it would be in the same range as the price of remdesivir in India, which roughly costs between Rs 2,800 and Rs 5,400 per dose.

 
From a manufacturing point of view, one does not need to invest much as it is already established, Navangul said. While pricing is still some way away, the firms feel that if a patient can avoid hospitalisation and intensive care by using the product, it will bring down the cost borne by the patient and the health care system.

 
Globally, Roche and Regeneron have collaborated to develop antibody products for Covid that are derived from recovered patients and VelocImmune mice. Severin Schwan, CEO of Roche, explained at a recent webinar that while some patients do not develop the right antibodies to fight the virus, some develop it relatively late. “If we can identify and give these people neutralising antibodies at early stages, there can be huge benefits. It can also be given as a prophylaxis to high risk individuals,” he said.

 
The Intas spokesperson said that approach will remain relevant even after a vaccine arrives as hyperimmune globulin also has potential for prophylaxis. Generally, there is a seven to ten day window to develop effective immunity after someone is vaccinated. If a healthcare worker or any high-risk individual is exposed to the virus in the meanwhile, a shot of hyperimmune globulin could be a life saver.


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