Intas Pharma COVID-19 specific Hyperimmune Globulin gets DCGI nod to conduct clinical trial

Hyperimmune Globulin also has potential for use as prophylaxis for all high-risk populations in contact with COVID-19 patients. This could be an important therapeutic option that can potentially help combat the disease until a vaccine is available.

Intas is among the world's first to adopt this approach for treating COVID-19 patients. This will be a Corporate Social Responsibility (CSR) initiative from Intas in collaboration with all Indian Blood Banks, which will help to procure convalescent plasma (plasma extracted from patients recovered from COVID-19 infection).

Intas has received permission from the Drug Controller General of India (DCGI), to conduct a clinical trial by using the newly developed COVID-19 specific Hyperimmune Globulin. After establishing its usefulness in the clinical trial, this product will be available for use in treating COVID-19 patients. Commenting on the development, Dr Alok Chaturvedi, Head of Medical & Regulatory Affairs, Intas, mentioned that "This endeavor is a testament to Intas' commitment towards meeting the unmet medical needs of the society through research-driven solutions."

Dr. Suma Ray, Vice President & Head of Plasma Operations at Intas, mentioned that Hyperimmune Globulin will provide purified and enriched preparation of COVID-19 specific neutralizing antibodies in high concentration, free from blood transmitted viruses and other plasma proteins. Hyperimmune Globulin will also enable consistent, precise dosing and predictable response early in the treatment of COVID-19 infections. Being a specific antibody treatment manufactured specially, it does not require blood group matching or donor selection while administering to the patient besides having huge benefits in terms of assured antibody administration. Unlike Plasma therapy, Hyperimmune Globulin can be readily administered to the patients anywhere even in the remotest part of the country.

Intas is establishing an alliance with medical and research institutions, blood donation groups to collect the plasma from recovered COVID-19 patients. Intas will shortly launch a website to help recovered COVID-19 patients to locate the nearest Blood Bank where they can safely donate plasma. The company seeks government support to facilitate the supply of convalescent plasma for the manufacturing of this enriched Hyperimmune Globulin and thereby help more patients conquer COVID-19.