The U.S. supply chain for key starting materials (KSMs), the building blocks needed to manufacture active pharmaceutical ingredients (APIs), is at risk due to America’s reliance on countries such as China and India for these critical chemicals.

In June, US Pharmacopeia (USP) released its annual drug shortages report and warned that U.S. reliance on single-country sourcing of KSMs and APIs has left the upstream supply chain susceptible to disruption.

“For drugs in shortage, this upstream concentration can present a significant and often hidden vulnerability,” the report states. “Among the 75 drug shortages, 33 rely on at least one KSM produced exclusively in a single country. Six drugs in shortage depend entirely on KSMs from one country: four injectable products sourced solely from China and two oral solids from India.”

What’s needed to lessen America’s reliance on other countries for these critical chemicals is for the U.S. to leverage fermentation processes used in brewing beer, according to Michelle Rozo, vice chair of the National Security Commission on Emerging Biotechnology (NSCEB).

“Think of the way we brew beer — we can brew chemicals the same way,” Rozzo told a Senate subcommittee hearing this week. “We could remake some of these supply chains with new innovative means of manufacturing.”

One company says it has the biomanufacturing technology needed to solve these critical U.S. supply chain challenges. Menlo Park, California-based Antheia claims it can end drug shortages with its biosynthesis platform, which utilizes advanced manufacturing technologies to produce biosynthetic KSMs and APIs for essential medicines in a more efficient, agile, and sustainable way.

Using engineered yeast cells, the pharmaceutical ingredient manufacturer converts sugars into complex molecules — Antheia’s biosynthetic KSMs and APIs — expanding the different compounds that can be produced through fermentation.

“This American-developed technology uses engineered microorganisms, rather than agriculture or chemical synthesis, to produce KSMs and APIs, unlocking faster production timelines and competitive pricing,” CEO and co-founder Christina Smolke wrote in a recent LinkedIn article.

Smolke contends that U.S. government investment in “brownfield retrofitting is the fastest path to deploying this technology at scale and building resilient supply chains for KSMs and APIs.”

Earlier this year, Antheia expanded the scope of its second project agreement with the Biopharmaceutical Manufacturing Preparedness Consortium (BioMaP), securing an additional $9 million to support domestic pharmaceutical manufacturing capacity. The funding brings the total project investment to $21 million to support efforts to produce two critical pharmaceutical ingredients at increased commercial scale domestically.

However, that’s a far cry from the $15 billion that a 2025 NSCEB report says the U.S. government must spend to maintain America’s global leadership in biotechnology and compete with China. On Tuesday, NSCEB’s Rozo warned the Senate subcommittee that “China is no longer merely catching up to us in biotechnology — in key domains, particularly in areas of biopharmaceutical innovation, they are now surpassing us.”

Rozo noted that China is doubling down on its strategic investments in industrial biomanufacturing and the associated infrastructure, as U.S. biomanufacturing faces several barriers including regulatory hurdles, inefficient biological yields, lack of standardization, and limited domestic scale-up capacity.

“This is an area that we emphasize in our report as a critical component of where biotech can be used to onshore critical chemicals that we now rely on from foreign sources or adversaries,” Rozo said.