COVID-19: RGCB products for pandemic management get manufacturing license

Ahmedabad

A cost-effective Rapid Antibody Card, developed indigenously by Government of India’s Rajiv Gandhi Centre for Biotechnology (RGCB) based in Thiruvananthapuram, Kerala, is among the three key products that have obtained manufacturing license, lending a cutting edge to COVID-19 management efforts in the country. The two other products of RGCB, which have been granted license by the Central Drugs Standard Control Organization (CDSO), are Viral Transport Media (VTM) kit and a viral RNA extraction kit.

These products have been developed by RGCB in partnership with Sperogenx Biosciences Pvt Ltd, Bengaluru, and POCT Services, New Delhi, under SARS-CoV-2 diagnostic umbrella. Of these, VTM and RNA kits have already been test-marketed. Sperogenx is the development partner and POCT the commercial partner. The other products of RGCB—Antigen detection system, ELISA and PCR kits—are under various stages of approval from the regulatory authorities in India.

The RGCB Director Professor M. Radhakrishna Pillai said that these products were a testimony of the commitment made by RGCB to the Government of India in its battle against Covid 19 infection. The Rapid Antibody Card will help study the presence of anti-SARS-CoV-2 IgG antibodies, with 100 per cent sensitivity and 98 per cent specificity. It has the advantages of being cost-effective, sensitive, and rapid. It also facilitates testing of a large number of samples at any level of clinical setting, public health centres and hospitals.

The VTM kit, formulated using raw material from Indian sources as per United States’ Centre for Disease Control (CDC) guidelines, is suitable for collection, transportation, maintenance and long-term storage of viral specimens. It helps preserve the viability of viruses for up to 72 hours at refrigerated temperatures. The swabs have been designed ergonomically with a pre-moulded breakpoint on their shaft. Though there are similar products available, this kit can be marketed at a price that is 30 to 35 per cent less. The RNA kit facilitates fast manual isolation of viral RNA from the swab. The process takes only 25 to 30 minutes to extract 95 per cent yield of RNA. It also has the price advantage as it is manufactured using raw material available in India.

The RGCB, in collaboration with POCT, is developing the ELISA kit that can be produced at lower cost. This is affordable and easy-to-use, and can be done in a resource-limited setting for a serological assay in multiple analyses at a time. It is also collaborating with Sperogenx to develop a COVID-19 Real Time Multiplex RT-PCR Kit for qualitative detection of novel corona virus. This is a three-gene system that detects N gene, E gene and RdRP gene of 2019-nCoV. This is also a fully indigenous product and has been submitted for final validation to International Centre for Medical Research and Training (ICMRT).

The other initiatives of RGCB include developing/modifying some existing treatment options for the COVID patients in India. The products under development in this category include intravenous IgG, isolation and purification of IgG from serum samples of COVID patients and use it intravenously as neutralization antibodies. Also, RGCB is collaborating with an Australian company having a fixed dose combination (FDC) to treat COVID. Unlike conventional method, this FDC is considered as a new drug and RGCB has initiated few bridging bioequivalent and bioavailability studies of this formulation. This will be tested on patients when the regulatory approval is obtained.