The US government is setting more goals around biomanufacturing efforts, with a vision for stronger supply chains and greater domestic production.
A 64-page report released by The White House on Thursday lays out “bold goals,” including an aim to produce at least a quarter of all active pharmaceutical ingredients in the US for small-molecule drugs within five years. While some of the report is centered around climate change and agricultural initiatives, it also presents goals for health and supply chain resilience.
“There have been relatively low financial incentives for reshoring these chemical manufacturing processes, especially for production of molecules with low-profit margins. Biomanufacturing pathways would create opportunities for cost-effective domestic API production,” the report said.
The government wants to implement several R&D goals, such as developing cell-based and cell-free systems to produce APIs and chemicals, along with improving access to new technologies and analyses of the models to reduce costs.
US government pledges $2B for new initiative on biomanufacturing
API production has been on the government’s mind lately, as it pledged $40 million last September to expand domestic API and antibiotic manufacturing, along with the production of materials related to medications and possible pandemic response.
For other health initiatives, the government set goals to boost the manufacturing speed of 10 common therapeutics by 10-fold in five years, although the specific drugs were not disclosed. It also wants to amplify the use of AI and machine learning in the discovery and production sectors, increase the manufacturing scale of cell therapies and reduce production costs by 10-fold in 20 years.
For improving cell therapy manufacturing time, the report said that there should be efforts toward de-risking and testing new biomanufacturing practices — and a wider public engagement effort for the acceptance of cell therapies, among other R&D initiatives.
Other efforts include better cell therapy manufacturing expertise and developing more technologies.
The report goes on to state that there are possible opportunities for both public-private partnerships and government incentives to try and make these efforts more of a reality.
The Omnibus spending bill passed in December 2022 also put $10 million toward creating centers of excellence for advanced and continuous manufacturing for pharmaceuticals, as well as other efforts to strengthen the supply chain.
Drug shortage solutions brought before Senate Homeland Security committee
