BIOSECURE: China’s loss could be India’s gain

Introduced to the US House of Representatives after the government found that certain Chinese companies had engaged in unethical actions, the BIOSECURE Act passed through the house in September, and if signed into law will restrict named Chinese biopharmaceutical companies from doing business in the US.

Chinese contract development and manufacturing organizations (CDMOs) including, most notably, WuXi Biologics, could – post 2032 – theoretically be off the table to drug developers leaving a substantial shortage of manufacturing capacity and expertise.

But such a political move could be an opportunity for Indian contract manufacturers. India has historically been a major player in the production of small molecules but is now teetering at becoming a major supplier on the large molecule front and BIOSECURE is only going to help drive this narrative.

“We are seeing quite significant demand being driven directly by the BIOSECURE Act,” Roger Lias, chief commercial officer of Aurigene Pharmaceutical Services and a biomanufacturing stalwart, told BioProcess Insider at Biotech Week Boston in September.

While he could not talk specifics, his firm – a wholly owned CDMO subsidiary of Indian pharma giant Dr Reddy’s – has seen “a lot of interest especially from large pharma companies at the moment, who are looking to, perhaps not get out of China, but not to put more into China […] Obviously we're happy to take advantage of that, but there's no doubt India is a viable alternative.”

Lias said from Aurigene’s capabilities perspective he is seeing a difference between early phase works of discovery services and early process development, versus later stage and commercial manufacturing.

“My impression, and it's just an impression, is that for small molecules we're seeing some things move out of China. For biologics, my impression, again, is we're seeing less stuff going into China, and India benefits from that.”

India is not the only region set to benefit from an embargo on Chinese capacity. South Korea is also likely to see an uptick in business. The country has become one of the largest hubs of mammalian capacity in the world thanks to significant investments led by CDMOs Samsung Biologics, Lotte, and others, and while Lias admitted India has not yet sewn such large biocapacity seeds, there is “significant” commercial manufacturing capacity available.

“At Aurigene, for instance, we have available in single use format up to 25,000 liters worth of capacity now, without the clinical scale. “We just brought on new clinical capacity as well. We specialize in mammalian systems. We have a limited ability to do some microbial work as well.

“Biocon and others have larger capacity, although it's largely captive. [And] on the CDMO side, our friends at Syngene, for instance, recently acquired a facility from Stelis, so it's building. And again, at Dr Reddy's and Aurigene, we're expanding quickly as well.”

Quotes have been lightly edited for clarity.