Social media murmurs: Industry contemplates supply chain post-BIOSECURE

The BIOSECURE Act, which aims at restricting Chinese companies – including major biologics contractor WuXi Biologics – from doing business in the US, passed through the US House in September with bipartisan support.With President-Elect Donald Trump’s animosity toward China well-documented, biomanufacturing commentators are now wondering how supply chains will be affected not just if but when the Act becomes law.

Audrey Greenburg, global head of advanced therapies contract development and manufacturing organization (CDMO) Center for Breakthrough Medicines (now part of SK pharmteco) cited a WSJ article and asked, “Is the US biotech industry ready to breakup with China?”

Posting on LinkedIn, the biotech business veteran said: “As tensions between the US and China escalate, the pharmaceutical and biotech sectors are facing a stark reality: their deep reliance on Chinese partners for manufacturing, research, and raw materials could become a liability.

”She said companies are “urgently diversifying supply chains to mitigate ‘China risk,’” with US players seeking partners elsewhere – in Europe and India, for example, which resonates with what sources have previously told this publication – and with WuXi Biologics expanding operations to Ireland (though whether this will bypass the rules of BIOSECURE is unknown).

Signing off by stating “transforming global supply chains isn't just a logistical challenge – it's a test of resilience,” she invited her army of industry followers to add their two cents, and they did not disappoint.

Spencer Knight, principal consultant for cell and gene therapy (CGT) at life-sciences recruitment firm Hartmann Young, said 80% of biotech suppliers are Chinese. However, Fresenius Hisham Kamoun, a field application specialist at Fresenius Kabi, noted biotech had already begun to diversify supply chains and find alternatives to Chinese suppliers as a result of COVID-19. “The BIOSECURE Act would surely provide a need to accelerate those efforts, and I'd imagine it's not easy to find alternatives for every single raw material,” he noted.

The urge to accelerate this was pushed by Ian Schacht, director of laboratory operations at Ractigen Therapeutics, due to what he described as the intellectual property risk of working with Chinese contract research organizations (CROs) and CDMOs. “Decoupling will cause price hikes in materials and supplies but will provide more safeguards for US interests. China may be a cheaper option to run analysis, but the cost of losing your IP to a company in a country that will protect domestic interests over foreign ones is clear.”

Self-proclaimed mass spectrometry and biomedical research enthusiast Graham Bell, from Shimadzu Scientific Instruments, meanwhile, made a call to “bring manufacturing in-house before we lose the skills needed to effectively supply specialty chemicals.

“Stop outsourcing for the cheapest possible price to make the bottom line look better for Wall Street. I know that’s an unpopular opinion in American business.”

Dharmesh Patel, a senior scientific advisor and consultant in the CGT space, disagreed. “In house is always good for strengthening our own interest, however things cannot be done in silos, and that's why I am a firm believer to have the right ethical collaborators and partners to solve affordability and enhance access to each part of the world. This will require larger involvement of governments as well as public and private sectors with keeping focus on ESG [environmental, social, and governance].

”Others jumped on the need to diversify, and the concept of inking deals with European and Indian CDMOs reflected key themes seen by Elucid8 Bio founder Ali Nobakht this week at Jefferies London Health Conference. But he said the real question is “How do we navigate these massive shifts in supply chains without losing sight of what matters most – improving patient outcomes?”

“For me, that’s where the heart of this discussion lies. How do we ensure resilience and innovation go hand-in-hand with delivering better care?”

And if you have any insight or comment as to how BIOSECURE will affect the biopharma supply chain, feel free to reach out to us here at BioProcess Insider.

Quotes have been lightly edited for clarity.