FDA Awards Grants to Bioprinting Institutions

Charles Goulding and Rafaella July of R&D Tax Savers explore the US FDA’s grants forwarding work in bioprinting.

The FDA has played a huge role in advancing the United States as a leader in 3D bioprinting. Recently, the federal agency granted five globally-recognized research institutions a combined $2.6 million for elevating research on biomanufacturing. In the given statement, Scott Gottlieb, MD and FDA Commissioner, reinforced the FDA’s support “for improvements in the reliability, flexibility, and cost-effectiveness of manufacturing for biological products.” The grants were awarded with expectations to “facilitate faster adoption of innovative technologies, while ensuring the safety and efficacy of biological products.”

The grants were given to institutions that have already demonstrated 3D bioprinting expertise, including:

• Harvard University

• Carnegie Mellon University

• Rutgers University

• Georgia Institute of Technology

• Massachusetts Institute of Technology         

Research and Development Tax Credits, which can then be used to continue R&D efforts, can support prospective commercialization of these developing technologies.    

Research and Development Tax Credit

Enacted in 1981, the federal Research and Development (R&D) Tax Credit allows a credit of up to 13 percent of eligible spending for new and improved products and processes. Qualified research must meet the following four criteria:

• New or improved products, processes, or software

• Technological in nature

• Elimination of uncertainty

• Process of experimentation

Eligible costs include employee wages, cost of supplies, cost of testing, contract research expenses, and costs associated with developing a patent.

On December 18, 2015 President Obama signed the bill making the R&D Tax Credit permanent. Beginning in 2016, the R&D credit can be used to offset Alternative Minimum Tax and startup businesses can utilize the credit against $250,000 per year in payroll taxes.

Wyss Institute at Harvard University

Immunotherapy is a way to treat disease by enhancing and equipping the body’s own immune cells against pathogens. It is considered a better method of fighting disease than traditional drug therapy; however it can take upwards of a month to produce. Harvard University was granted $599,910 to advance their immunotherapy treatment research. The institution developed a method to hasten the process by creating customizable scaffolds that act as antigen-presenting cells to stimulate immune cell production. A more efficient process will induce more widely available and expeditious immunotherapy treatment for ill patients that do not have time to waste.

Georgia Institute of Technology

Georgia Institute of Technology is another institution that has played a role in progressing research on immunotherapy. The university’s team of researchers was granted $600,000 to continue their work on immune-modulation and tissue-biofabrication of mesenchymal stem cells (MSC). MSC are undifferentiated cells that can be specialized and become a specific type of cell including bone cells, cartilage cells, muscle cells, or fat cells. MSC can be used to treat a deficiency in the body.   

Carnegie Mellon University

Carnegie Mellon University was granted $599,844 for their research on 3D printing porous electrodes for lithium-ion batteries. A battery’s capacity can be significantly improved if its electrodes have pores and channels due to the increased electrode utilization percentage. 3D printing allows the design and architecture to be precisely controlled in order to optimize the functionality of lithium-ion batteries.

Rutgers University

Rutgers University was granted $600,000 to continue working on a number of biotechnological projects, including an automated blood drawing and testing device. The device includes a venipuncture robot, a sample handling module, and a blood analyzer. It was designed to provide rapid test results for urgent situations such as in ambulances or emergency rooms.

Massachusetts Institute of Technology (MIT)

The FDA granted Massachusetts Institute of Technology $600,000 for their research on viral vector manufacturing. Viruses replicate by inserting their genes into a host cell’s DNA and reproducing as the cell goes through its own reproduction cycle. Viral vectors are a key technology for neuroscience research because it allows researchers to experiment and see the affects of viruses on brain function.

Conclusion

The FDA has placed a tremendous emphasis on the importance of advancing biomanufacturing. Not only will the grants help to further develop biotechnology and transform the healthcare and pharmaceutical industries, but it will also uphold the United States as a leader in the global biomanufacturing and 3D printing market.