FDA regulates pharmaceutical products to ensure a continuous supply of high-quality products in the United States. In regulating the pharmaceutical manufacturing sector, FDA realizes the need for a maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high quality biologics. To help achieve this vision, the Center for Biologics Evaluation and Research (CBER) encourages the development and adoption of advanced technologies to modernize biopharmaceutical manufacturing. Such a modernization effort aims to result in a more robust manufacturing process with fewer interruptions in production, fewer product failures (before or after distribution), and greater assurance that the biologic products manufactured will provide the expected clinical performance. CBER recognizes that the implementation of emerging technologies for manufacturing high-quality complex biologics could present a variety of challenges for both CBER and industry.
To address these challenges, CBER has awarded several grants and contracts to support research projects to promote the development and adoption of innovative approaches for the manufacture of CBER-regulated products. CBER solicits applications for extramural funding through the FDA Broad Agency Announcement (BAA) (SAM.gov), and the NIH Grants & Funding portal (grants.nih.gov).
Special Notice of Funding Opportunity
The FY22 FDA BBA was recently published (SAM.gov). FDA solicits for advanced research and development proposals to support regulatory science and innovation. The FDA anticipates that research and development activities awarded under this BAA will serve to advance scientific knowledge to accomplish its mission to protect and promote the health of our nation. Prospective Offerors are encouraged to submit white papers no later than 5:00 pm, Eastern Standard Time, January 21, 2022, and earlier if possible. White papers submitted after that date will still be accepted, but due to a lack of lead time, will not be considered for award in FY22.
The target areas of interest to the CBER Advanced Technologies Program are outlined in section 3.1, specifically subsections 3.1.5 and 3.1.6. The initiative described in subsection 3.1.6 (Demonstration unit for GMP continuous manufacturing of mRNA vaccines) is especially of high priority for CBER given its potential impact in addressing current and future pandemics. Given this significance, the center intends to allocate significant resources for its development.
FY18 RFA-FD18-023: Enhancing Innovations in Emerging Technologies for Advanced Manufacturing of Complex Biologic Products (R01)
- Harvard University (Cambridge, MA); Scaffolds Mimicking Antigen Presenting Cells
- Carnegie-Mellon University (Pittsburgh, PA); Advanced Manufacturing of Regenerative Extracellular Matrix Scaffolds
- Rutgers University (Piscataway, NJ); Advanced Continuous Upstream Manufacturing of Biotherapeutics
- Georgia Institute of Technology (Atlanta, GA); Data Enabled Automation for the Improved Efficacy, Yield and Reproducibility of the Manufacturing of Mesenchymal Stromal Cells for Clinical Therapeutic Use
- Massachusetts Institute of Technology (Cambridge, MA); Continuous Viral Vector Manufacturing based on Mechanistic Modeling and Novel Process Analytics
FY20 RFA-FD20-032: AAV vector manufacturing for diseases affecting very small populations (R01) Clinical Trial Not Allowed
- General Electric Global Research Center (Niskayuna, NY); Simplified and Agile AAV Production by Integrating Rapid DNA Synthesis with Continuous AAV Collection
- Massachusetts Institute of Technology (Cambridge, MA); Flexible Platform for End-to-End Manufacturing of Gene Therapies to Advance the Development of Treatments for Ultra-rare Diseases
FY21 RFA-FD21-033: Enhancing Innovations in Advanced Manufacturing Technologies for Vaccines against Influenza and Emerging Infectious Diseases (R01) Clinical Trial Not Allowed
- Michigan Technological University (Houghton, MI); Integrated and Continuous Manufacturing of an Influenza Vaccine
- George Mason University (Fairfax, VA); Manufacturing and Characterization of Potent mRNA Lipid Nanoparticle Vaccines at Multiple Scales
- University of Texas at Austin (Austin, TX); A Novel First-in-class 3D Printing Technology for Advanced Manufacturing of Complex Vaccine Formulations against Influenza and Emerging Infectious
- Massachusetts Institute of Technology (Cambridge, MA); A modular platform for rapid VLP vaccine development and manufacturing for SARS-CoV-2 pandemic response
FY21 RFA-FDA-034: AAV Vector manufacturing for diseases affecting very small populations (R01) Clinical Trials Not Allowed
- North Carolina State University Raleigh (Raleigh, NC); Platform for Rapid Expression, Purification, and Analysis of Patient-Specific Gene Therapy Products
- Massachusetts Institute of Technology (Cambridge, MA); Continuous Production of Viral Vectors using Membrane-less Perfusion Culture of Host Cells
- University of California Irvine (Irvine, CA); Engineered AAV Vectors for Combinatorial Treatment of Rare Genetic Brain Diseases
- University of North Carolina Chapel Hill (Chapel Hill, NC); Nanopore Methods for Determining Capsid Viability
- University of Minnesota (Minneapolis, MN); Optimized Production and Validation of Rationally Designed AAV Vectors for Cockayne Syndrome Gene Therapy
Contracts Awarded through the FDA Broad Agency Announcement Program
FY19 FDABAA-19-00123: Food and Drug Administration Broad Agency Announcement for the Advanced Research and Development of Regulatory Science
- Southwest Research Institute (San Antonio, TX): Evaluate the Safety and Quality of a 3D Printed, Single-Use Bioreactor for Beads-Free CART T-cell Manufacturing
- Draper Laboratory (Cambridge, MA): Continuous Acoustic Separation for Therapeutic Cell Manufacturing
- University of Maryland (College Park, MD): Nondestructive Analytics for Vaccines and Complex Drugs
FY20 FDABAA-20-00123: Food and Drug Administration Broad Agency Announcement for the Advanced Research and Development of Regulatory Science
- Georgia Institute of Technology (Atlanta, GA): Identification of Critical Quality Attributes of Cell Therapy Products by Multi-omics Analyses and Predictive Modeling
FY21 FDABAA-21-00123: Food and Drug Administration Broad Agency Announcement for the Advanced Research and Development of Regulatory Science
- Massachusetts Institute of Technology (Cambridge, MA): Technologies to Enable Continuous Production of rAAV from Sf9/baculovirus Culture
These grants and contracts aim to address knowledge and experience gaps identified for emerging manufacturing technologies and support the development and adoption of such technologies in the biological product sector. The agency will continue to support efforts to develop the standards, policies and policy guidance needed to foster the effective and efficient development and adoption of new manufacturing platforms.
For more information, please refer to the CBER Advanced Technologies Program
For funding Opportunity Announcements, please visit the following websites:
Contracts (FDA Broad Agency Announcement): SAM.gov