SBIR Phase II: A novel 3D bioprinting system for rapid high-throughput tissue fabrication

The broader impact of this Small Business Innovation Research (SBIR) Phase II project is to provide a high-throughput biofabrication platform that can create physiologically relevant in vitro tissue models for diverse applications including drug testing, assay development, therapeutics, and biomedical research. The current drug development process is lengthy, inefficient, and expensive. It costs about $1.8 billion and takes 12-15 years to launch a single drug. Approximately 92% of the drugs that passed preclinical testing failed in subsequent human trials, highlighting the lack of adequate preclinical testing tools to generate predictive data. Failure to detect the drug-induced toxicity to the vital human organs in clinical trials often leads to market withdrawal of the drug after launch, which causes enormous financial losses to the drug manufacturer and also negative physical and mental effects for patients. The proposed technology will significantly improve drug safety, increase the efficiency and lower the cost of drug development by providing more reliable and clinically relevant drug testing results in a high-throughput fashion. This technology can also provide patient-specific tissues for critical biomedical research (e.g. disease modeling) and in vivo therapeutic applications, providing a viable solution to diseases without no cures or effective treatment yet. This Small Business Innovation Research (SBIR) Phase II project will support the development of a high-throughput biofabrication platform that is compatible with the high-throughput screening (HTS) systems widely used for drug screening and assay development. Currently, the key bottleneck for traditional microfabrication strategies and mainstream nozzle-based bioprinters is the lack of scalability and throughput to accommodate scalable manufacturing necessary in HTS systems. With the growing adoption of 3D biomimetic human tissue models in the pharmaceutical industry, there is a critical need for advanced manufacturing systems that enable rapid and streamlined tissue fabrication methods that are compatible with already established HTS platforms for preclinical toxicity testing of potential drug candidates. The proposed project will develop a parallel optical projection-based 3D bioprinting platform for direct manufacturing of 3D tissues within multiwell plates commonly used in the HTS systems. Implementation of the proposed 3D bioprinting system will permit subsequent in situ drug screening or assay testing directly within the wells and drastically improve biofabrication workflow efficiencies for the pharmaceutical industry and biomedical research community. This bioprinter will serve as a powerful instrument for the mass production of 3D tissue models at the industrial scale to advance drug discovery and assay development. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.