From cell therapies to US-made ingredients, White House outlines new drug manufacturing goals

Looking to tackle issues ranging from climate change to cell therapy production, the Biden administration has laid out a panoply of biomanufacturing goals.

The initiative seeks to, among other things, improve supply chains for critical drugs and better predict future supply chain disruptions like the sort seen over the past several years. More specifically, within the next five years, the Biden administration aims to use biomanufacturing to produce some 25% of active pharmaceutical ingredients for small-molecule drugs in the U.S.

Currently, many drug ingredients bound for the U.S. are made in countries such as China and India.

The government also seeks to predict “at least 50%” of supply chain weaknesses and use biomanufacturing “adjustments” to contend with supply bottlenecks, according to a recent report (PDF) titled “Bold Goals for U.S. Biotechnology and Biomanufacturing.”

The team envisions the rollout of real-time biomanufacturing process adjustments in the next five years. Over the next 20 years, the goal is to be able to tackle those bottlenecks “within one week of identification.”

The Biden administration also wants more companies to power bioproduction of medicines with artificial intelligence. This could both improve on the speed and diversity of drug manufacturing and assist with the design of new therapies, the report argues.  

Finally, the report encourages the development of new strategies and techniques for gene editing, again with a focus on expanding access and enabling new therapeutics.

The report sheds light on an initiative President Joe Biden announced in September, when he issued an executive order calling for investment in genetic engineering and AI along with the removal of commercialization obstacles.

To further those aims, the Biden administration plans to plug federal investments into biotech and biomanufacturing R&D as well as domestic biomanufacturing production capacity, according the report.

Last year's order followed a June 2021 pledge to establish a public-private partnership to pinpoint 50 to 100 essential medicines for an “enhanced onshoring” effort. At the time, the government earmarked about $60 million to research new technologies to boost domestic API production.