Biotechnology Applications from Space for Earth

The National Aeronautics and Space Administration (NASA) In Space Production Application (InSPA) Portfolio seeks proposals under the Small Business Technology Transfer (STTR) Program to accelerate commercial scale production in space of superior biotechnology materials and products for important Earth applications that meet FDA standards. A special focus of this STTR is on projects that use space to accelerate solutions to intractable childhood diseases. Proposers should plan to implement projects in Low Earth Orbit (LEO). Sponsored by the International Space Station (ISS) Program, InSPA is a flight development program that supports innovative US companies to use microgravity and other space assets to deliver superior products for Earth, rather than space, applications. Most companies in the InSPA Portfolio are small businesses. Over the past five years, InSPA and ISS National Lab sponsored projects delivered exceptional results from microgravity research and manufacturing development on ISS focused on medical applications for patients on Earth. They demonstrated the value of microgravity to accelerate and enable medically important advances in ways that are not possible in terrestrial gravity The major areas where microgravity has proven effective are the initial focus of this activity and include improving the speed and accuracy of diagnoses for critical diseases; improving and accelerating better treatment options and therapeutics; and enabling new medical devices and pharmaceuticals to a quality not possible on Earth. The results, which are available in numerous peer reviewed publications, are expected to help inform potential proposers of the kinds of processes and projects that require scaleup. Several InSPA biomedical projects are ready to begin developing spaceflight manufacturing technologies to commercial scales. However, current equipment, which was designed for small batch research and not manufacturing on ISS, requires new technologies to enable the automation, quality control, FDA Good Manufacturing Processes, and repeatability needed for FDA approval of products. The goal of this STTR is to help enable, accelerate, and demonstrate repeatable, scalable biotechnology production in orbit for medical applications on Earth. New assistive devices added to or incorporated in proven technologies are needed to enable 10X or higher throughput from each flight opportunity that efficiently uses the accommodations and constraints of the ISS and/or commercial vehicles and delivers the quality and quantity necessary to make in-space manufacturing profitable. These include but are not limited to: Artificial Intelligence (AI)/Machine Learning (ML) Analyses and Modeling of microgravity dynamics are important to medical applications that inform scaleup designs and commercial scale processing. AI/ML Analyses of biomedical spaceflight results combined from multiple projects to obtain new knowledge from existing data important for developing new medical applications for Earth. Focus should be on results obtained over the past decade, but especially over the past five years, on ISS. Better inflight imaging, sensors and analytics for monitoring, process management, metrology and quality control inflight. Robotics to automate and ensure precision in exchanging feedstock for finished products; precisely injecting biomarkers, fixatives, and other chemicals at intervals through the growth processes of cells and tissues, including stem cells; moving samples from an incubator to refrigerator/freezer; enabling imaging of biomaterials as they develop in space; and many other functions that enable repeatability, precision, and ability to hold cells, tissues, and organoids in the "sweet spot" where the best results are obtained in space. Identify and flight qualify relevant commercial off the shelf terrestrial medical research and manufacturing hardware to leverage standardized systems used on Earth. This enables effective comparisons between flight and ground processing and/or significantly reducse development time and cost of high throughput systems.