Boost for biologics

Mumbai-based Resolve Biotech was set up during the COVID-19 pandemic to make a point-of-care test for the SARS-CoV-2 virus amid a shortage of such tests. When the pandemic ended, so did the demand-supply mismatch. But Resolve had a manufacturing facility, so it began scoping out other areas that lacked a reliable, local supply chain, says Managing Director Ram Khanna. It found these in consumables and equipment used to make biopharmaceuticals.

With its own research and development lab and an upgraded facility, Resolve now manufactures buffers, media, cytokines, and growth factors used in mammalian and microbial cell cultures. Cells are cultured for research and to manufacture a range of biologics, vaccines, and cutting-edge cell and gene therapies (CGT). Resolve's products are vital components of cell culture. Media comprise specialised nutrients to nourish cells. Cytokines and growth factors regulate cell proliferation and differentiation. Buffers help maintain stable pH levels for cell growth.

"Our play is pure import substitution," Khanna says. Wherever it can, Resolve wants to provide customers with an alternative to the $40-billion U.S.-based Thermo Fisher group, a dominant supplier. Resolve's engineering division manufactures patented peristaltic pumps, among other things, designed to move cells gently between vessels to prevent damage to biomolecules. It competes with companies such as Watson-Marlow of the U.K. and PSG of the U.S.

In Ahmedabad, OmniBRx Biotechnologies has a novel and patented technology platform for adherent cell culture. Most mammalian cells are adherent; they need a matrix or surface to adhere to in order to grow. There are established methods to adapt such cells to grow in suspension. But where this isn't possible, scale-up demands an ever bigger geographical footprint and large volumes of consumables. Scalability, efficiency, and affordability are critical hurdles of this type of cell culture, says OmniBRx's Global Strategy Officer Jagadish Bennale.

OmniBRx has a compact system that efficiently enhances the surface area for cells to grow. It economises on consumables such as media while ensuring all cells get the nutrition they need. The vaccines industry depends heavily on roller bottles — a decades-old, labour-intensive tech in which the initial culture is filled into multiple bottles, which are then stacked and moved around, Bennale says. However, the company claims that a 200-litre bioreactor can replace over 17,000 roller bottles and needs two staffers instead of 25. It has also begun to supply mini bioreactors for culturing mammalian cells, such as T cells, that thrive in suspension, at a heavy discount to European incumbents. Unlike Resolve, OmniBRx bioreactors are distributed in multiple countries, though most of its installations are in India.

India is home to a fast-growing, dynamic biopharmaceuticals sector. It hosts leading global manufacturers of vaccines. Its drug companies have invested heavily in producing patent-expired biologics. There is stepped-up research and start-up activity in cutting-edge therapeutics such as CGT. But large swathes of the sector depend heavily on overseas suppliers for the core inputs and equipment. Start-ups such as Resolve and OmniBRx are emerging in areas where homegrown companies are an exception.