FDA Policy/General

OSTP Goals for Biotechnology and Biomanufacturing

A White House Office of Science and Technology Policy report, “Bold Goals for U.S. Biotechnology and Biomanufacturing,” provides 10 goals that highlight what could be possible with the power of biology. “These goals are intended to provide a broad vision for the U.S. bioeconomy and what can be achieved with concerted action from industry, academia, nonprofits, the federal government, and other organizations,” the report says.

The report contains a section (pg.26) entitled “Biotechnology and Biomanufacturing R&D to Further Supply Chain Resilience” that examines how new biotechnologies and biomanufacturing processes have the potential to help mitigate the risks and effects of supply chain disruptions. “Synthetic biology can be used to replace existing production processes, such as for precursor materials, and to create new products, resulting in new opportunities for diversifying production pathways and alleviating supply chain chokepoints,” it says. “For example, realizing biomanufacturing breakthroughs for active pharmaceutical ingredients (APIs) has the potential to create environmentally sustainable, domestic alternatives to API production, which is currently heavily concentrated abroad.”

The section basically provides a vision for harnessing research and development advances in biotechnology and biomanufacturing to build supply chain resilience. For example, it says a five-year goal should aim at deploying “broad synthetic biology and biomanufacturing capabilities to produce at least 25% of all APIs for small molecule drugs here in the U.S.” Its 20-year goal would see “adaptive supply chains” that could “deploy a suite of advanced biomanufacturing platforms and capabilities to respond to supply chain bottlenecks within one week of identification.”

The 10 goals in the report are listed under four themes:

the need to develop more carbon-neutral transportation and stationary fuels;
alternative processes to produce chemicals and materials;
developing climate-focused agricultural systems and plants; and
addressing carbon dioxide removal.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome