Description: LambdaVision has developed a protein-based artificial retina to restore vision to the millions of people blinded by retinal degenerative diseases, including retinitis pigmentosa and age-related macular degeneration. The implants are manufactured using a layer-by-layer (LBL) assembly technique, in which alternating layers of the light-activated protein, bacteriorhodopsin, and a polycation binder are sequentially deposited onto an ion-permeable film. Preclinical evaluation of the technology demonstrated the ability to stimulate degenerated retinal tissue and safely insert the implant into the subretinal space of animal models. However, the outcome of these efforts is dependent on the quality of the LBL-assembled artificial retinas. We have observed that the terrestrial LBL approach is influenced by gravity, in which sedimentation and gradients of solutions interfere with homogeneity and quality of the multilayered films. Our expectation is that manufacturing in a microgravity environment will improve the quality, stability, and performance of the artificial retinas. In collaboration with Space Tango, LambdaVision has completed a series of microgravity experiments that have established a foundation for producing artificial retinas using a low-Earth orbit platform. In this Phase II-E proposal, we will utilize terrestrial-based research efforts to achieve, (1) the completion of an LBL manufacturing device with improved fluidic parameters and material selection, (2) an implemented UV-C sterilization method that will be used to reduce bioburden of solutions for long-term use on orbit, (3) a refinement of confocal microscopy techniques to quantify the light-induced proton gradients of the artificial retinas, and (4) the development of a method to estimate protein loading across the films using high-resolution imaging spectroscopy. This Phase II-E proposal represents critical research and development activities that will ensure the success of future missions on the ISS.

Benefits: This Phase II-E SBIR establishes the capabilities required to support LEO commercialization of protein-based artificial retinas. The artificial retina is intended to treat patients with retinal degeneration, a leading cause of blindness for millions around the globe. The work outlined will support a new sector in the LEO economy, which utilizes the impact of microgravity on physical systems to improve current production methods for patient therapies.

An enhanced layer-by-layer manufacturing process can improve the homogeneity, orientation, and stability of multilayered thin films for broad applications, including artificial retinas, photovoltaic cells, chemical sensors, drug delivery systems, and tissue engineering. Efficient ordering of biomaterials is of interest to scientists with technologies across therapeutic and biomedical sectors.