SBIR-STTR Award

This Small Business Innovation Research Phase I project will develop customizable cell/tissue culture platforms using a new class of 3D printable bisphenol A-free polycarbonate (BFP) materials and a rapid 3D printing system. The 3D cell culture market was valued at $683 million in 2017 with an exponential projected growth in revenue valued at $1.7 billion by 2022. The rapid growth in this sector is primarily driven by the demand for custom-made 3D cell/tissue models that more accurately recapitulate the human in vivo biology in comparison to conventional animal models and planar cell culture systems. 3D cell/tissue models have the potential to provide more physiologically relevant responses for the drug discovery industry which is estimated to reach $86 billion in 2022. The proposed strategy of using BFP and a fully integrated benchtop 3D printing system will facilitate the production of different cell/tissue culture platforms on demand and enable rapid iteration of different designs to drive forward the development of more clinically relevant cell/tissue models for a broad market in pharmaceuticals, biotechnology, and biological studies.The intellectual merit of this project lies in: (1) the development of novel 3D printable BFP materials with tunable material properties using green chemistry, and (2) the rapid 3D printing of customizable cell/tissue culture prototypes to support various 3D cell/tissue models. The material development will include the establishment of a reagent library and optimization of the green chemistry process. The relevant material properties such as stiffness, elasticity, optical transparency, and small molecule adsorption will be characterized and optimized. These materials will then be printed using a rapid light-based 3D printer to prototype cell/tissue culture platforms followed by evaluation of their performance. In particular, 3D printing precision and resolution will be characterized and optimized by varying a range of fabrication parameters such as light exposure time and intensity. Next, the efficacy of the prototypes under cell culture conditions will be assessed based on device integrity, material degradation, as well as changes in mechanical and optical properties. Various cells/tissues will also be cultured on these prototype devices to evaluate biocompatibility. These achievements will provide customized culture platforms to facilitate the engineering of more physiologically relevant in vitro models for accelerating drug discovery and biological studies in both industry and academia.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.

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.