HHS Outlines Actions for New National Biotechnology and Biomanufacturing Initiative

The US Department of Health and Human Services (HHS) has announced actions the department will take following the issuance an executive order by President Joe Biden to launch the National Biotechnology and Biomanufacturing Initiative (see related story, President Biden Issues Executive Order To Advance Biomanufacturing, Biotech). The measures include a collaboration with the US Department of Defense to invest $1 billion in bio- industrial domestic manufacturing infrastructure over five years.

The actions that the HHS will take are as follows:

  • Collaborate with the Department of Defense to invest $1 billion in bio- industrial domestic manufacturing infrastructure over five years. This support will provide incentives to enable private- and public-sector partners to expand manufacturing capacity for products important for defense supply chains.
  • Invest $40 million to expand the role of biomanufacturing for active pharmaceutical ingredients, antibiotics, and industrially relevant key starting materials needed to produce essential medications and respond to the current or a future pandemic.
  • Support development of US Food and Drug Administration (FDA) research programs for advanced manufacturing technologies in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) to fuel multiple intramural and extramural research projects (e.g., smart data analytics and novel process analytic technology for bioprocessing and continuous manufacturing of biological products) to build a knowledge base in support of regulatory assessment, as well as scientific standard, guidance, and policy development.
  • Support development of the Advanced Manufacturing Innovation Hub in the FDA’s Office of Counterterrorism and Emerging Threats to create regulatory science benchmarks and strategies for platform technologies and to drive collaborations that affect multiple product areas (e.g., smart manufacturing, closed-loop process controls).
  • Support development of the FDA Center for Advancement of Manufacturing Pharmaceuticals and Biopharmaceuticals to enhance coordination and collaboration of science, regulatory, and policy activities between CDER and CBER.
  • Offer additional pre-submission support for applicants looking to adopt advanced manufacturing technologies through CDER’s Emerging Technology Program, CBER’s Advanced Technologies Team, and the FDA Center for Devices and Radiological Health’s Advanced Manufacturing Clearinghouse to provide more opportunities for drug, biologics and device manufacturers to engage with the FDA.
  • Work with international regulators in harmonizing requirements for innovation, including the development of the ICH Q13 guideline on continuous manufacturing of drug substances and drug products, the ICH Q5A guideline on viral safety evaluation of biotechnology products derived from cell lines of human or animal origin, and the ICH Q14 guideline on analytical procedure development.
  • Support the development of animal products produced with biotechnology, whether intended for agricultural or bio/pharmaceutical use, through the Veterinary Innovation Program at the FDA’s Center for Veterinary Medicine.
  • Continue to fund predoctoral research internships in the biotech industry through the National Institute of General Medical Sciences.
  • Innovate treatments using pilots, such as the National Centers for Advancing Translational Sciences Platform Vector Gene Therapy (PaVe-GT) pilot program, which is testing whether it is practical to use the same gene-delivery system and manufacturing methods for multiple rare diseases in gene-therapy clinical trials. The results from PaVe-GT will be made publicly available and can therefore be used to benefit subsequent adeno-associated virus gene therapy efforts.
  • Expand cell engineering capabilities and platforms and establish synthetic biology approaches through programs such as the Biopharmaceutical Development Program at the Frederick National Lab, which is developing a new cell line to treat acute myeloid leukemia, a particularly aggressive form of pediatric blood cancer.
  • 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. HHS will prioritize investments in applied biosafety and biosecurity innovation and use federal investments to incentivize and enhance biosafety and biosecurity practices throughout the US and its partners abroad from biological incidents. HHS will build the US innovation base for countermeasures, diagnostics, and biosurveillance information technologies, and advance the biomedical industries’ biodefense capabilities.

Source: US Department of Health and Human Services