Bengaluru-based firm produces two key enzymes for Covid-testing kits
As India has ramped up its Covid-19 testing capacity along with a push in domestic production of test kits, Bengaluru-based biotech company Richcore Lifesciences with help from scientists at the Indian Institute of Science, Bengaluru, and Indian Institute of Science Education and Research at Pune and Chandigarh have produced two key enzymes which are the main components of the reverse transcription polymerase chain reaction (RT-PCR) test kits.
With the ongoing pandemic, availability of the two enzymes —Taq Polymerase and Reverse Transcriptase — has been an impediment towards mass production of indigenous RT-PCR testing kits both in India and across the globe.
At present, these enzymes are imported and therefore, are very expensive. The lockdown has also proved to be an obstacle in the procurement process.
To detect the presence of the Sars-cov-2 virus that causes Covid-19, nasal and throat swab samples of symptomatic individuals are tested with RT-PCR method — considered the gold standard for Covid-19 diagnosis — and a positive or negative report is available within two hours to two days.
“These two enzymes are very critical to RT-PCR diagnostic kits because it allows conversion of the virus RNA to DNA. DNA is then amplified to make CDNA (copies of DNA) which confirms whether or not an individual is tested positive Covid-19,” said R
Subramani, chairman and managing director, Richcore Lifesciences, which is part of the National Biomedical Resources Indigenisation Consortium (NBRIC) constituted by the department of biotechnology on May 5.
“The enzymes can be produced by small laboratories, but do so standardised quality and Usfda-approved CGMP certification is important. These enzymes form a key bottleneck in India’s efforts to mass-produce indigenous testing kits,” said Subramani.
Currently, samples of the enzymes are being supplied to diagnostic testing kit manufacturers to confirm stability and consistency. “Once approved, we will be able to mass produce cgmpcertified enzymes for millions of testing kits in a few weeks,” said Subramani.
Traditionally, reagents such as enzymes are the building block for any diagnostic kit. “We have always been dependent on importing reagents owing to lack of quality and scalability in India. Even if procurement took time, the situation didn’t call for panic,” said Taslimarif Saiyed, chief executive officer and director, Centre for Cellular and Molecular Platforms, Bengaluru.
“But with the current situation, we are slowly and steadily realising that we need the reagents not only now but also going forward as we cannot rely on importing them,” said Saiyed.
In addition to the high cost and increase in global demand for reagents, imports have also been hampered owing to the ongoing lockdown.
“Therefore, even if start-ups or homegrown companies develop protocols for indigenous diagnostic kits, they need reagents to manufacture them. Domestically producing important enzymes as well as testing kits can make us self-reliant in the future,” said Saiyed, who is also a convener of NBRIC governing council. NBRIC is a public-private partnership to boost indigenous innovations focused on developing reagents, diagnostics, vaccines and therapeutics for Covid-19.