As part of President Joe Biden’s wide-ranging executive order to bolster U.S. biomanufacturing, the HHS has laid out detailed actions that include regulatory support for advanced manufacturing technologies and hefty investments in drug production infrastructure.
A collaboration between the Department of Defense and the HHS will invest $1 billion in domestic biomanufacturing infrastructure over five years, the federal health department said Wednesday.
“This support will provide incentives that will enable private- and public-sector partners to expand manufacturing capacity for products important for defense supply chains, such as critical chemicals,” the HHS said.
In a separate investment focused on medicines, the HHS said it will pour $40 million into expanding biomanufacturing for active pharmaceutical ingredients, antibiotics and key starting materials for essential medications needed for current or future pandemic responses.
For its part, the DoD will shell out an additional $200 million to enhance biosecurity and cybersecurity measures for those facilities supported under the $1 billion fund.
The investments are part of the agencies’ plan to implement Biden’s new National Biotechnology and Biomanufacturing Initiative, which besides medicines, also touches on agriculture, energy and other industries. The presidential order gives HHS and other federal agencies 180 days to provide policy recommendations to expand domestic biomanufacturing capacity for medicines and in other sectors.
The HHS has invested directly in drug and vaccine manufacturing in response to recent health crises. During the early days of the pandemic, Operation Warp Speed, in which HHS played a key role, offered financial support to the development and manufacturing of COVID vaccines. More recently, to combat the ongoing monkeypox outbreak, the HHS announced $11 million in funding to support domestic manufacturing of Bavarian Nordic’s Jynneos vaccine at contractor Grand River Aseptic Manufacturing.
Meanwhile, the new executive order is widely viewed as part of a strategy to reduce the U.S. reliance on China for pharmaceuticals and manufacturing of other biotech products.
Biden’s order does include a big focus on biosecurity amid increased geopolitical tension with China and after the COVID-19 pandemic served as a poignant reminder of the vulnerabilities in global drug supply chains.
For HHS, the agency said it will launch a biosafety and biosecurity innovation initiative in collaboration with the National Institutes of Health to “reduce risk associated with advances in biotechnology, biomanufacturing and the bioeconomy,” although the exact work of the initiative remains unclear. It will also prioritize investments in those areas.
Besides infrastructure, the executive order also calls for regulatory support for biotech R&D. In several measures that involve the FDA, the HHS said it will support development of FDA research programs for advanced manufacturing technologies. The agency raised the examples of novel analytics for bioprocessing and continuous manufacturing of biologicals.
The FDA currently has a research initiative to help better understand the science of advanced manufacturing. The program has backed 60 research projects, and the FDA has used the knowledge gained to provide industry guidance, according to an FDA post as of October 2021.
Last June, the FDA formally established the Center for Advancement of Manufacturing Pharmaceuticals and Biopharmaceuticals to improve collaboration between its two drug evaluation departments, one focused on traditional small-molecule and antibody drugs, and the other on live biotherapeutics and cell and gene therapies.
Under the HHS plan, the FDA will also provide opportunities for additional pre-submission interactions for drug, biologics and device manufacturers that look to adopt advanced manufacturing technologies.
The HHS will continue to support innovations in platform technologies, and cell and gene therapies are apparently among the agency’s priorities.
In its announcement Wednesday, the HHS highlighted the NIH’s Platform Vector Gene Therapy pilot project, which has been evaluating adeno-associated viral vectors as gene delivery systems since 2019. It also pointed to the CAR-T project at the Frederick National Laboratory.