Implementation of a Layer-by-Layer Manufacturing Apparatus for the Assembly of Protein-Based Retinal Implants in Low Earth Orbit

LambdaVision has developed a protein-based retinal implant to restore vision to the millions of people blinded by retinal degenerative diseases, including retinitis pigmentosa and age-related macular degeneration. Preclinical evaluation of the technology demonstrated the ability to reproducibly stimulate degenerated retinal tissue and safely insert the implant into the subretinal space of both rats and pigs. 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 are sequentially deposited onto a film. However, the current terrestrial LBL approach is influenced by gravity, in which sedimentation and gradients of solutions interfere with the quality of the implants. We hypothesize that manufacturing in a microgravity environment will improve the quality of the films and, as a result, will enhance stability and performance for future preclinical and clinical trials. A pilot manufacturing trial was carried out on the ISS via SpaceX CRS-16, which resulted in the proof of concept of creating multilayered thin films using a LEO platform. Subsequently, a Phase I SBIR effort allowed us to perform a series of parameterization experiments for follow-on spaceflight optimization. In this Phase II proposal, we will build on the terrestrial-based findings to achieve the following: (1) the completion of a LBL prototype with optimized parameters for implementation in microgravity, (2) the design of a chamber configuration that supports scale up for nonclinical non-GLP toxicity studies in a large animal model, and (3) a proof of concept of utilizing the LBL microgravity device for additional applications beyond the proposed use in vision restoration. This Phase II effort fits in to NASArsquo;s strategic plan for commercialization in LEO to build a sustainable production pipeline for this technology and for forthcoming technologies in the biomedical sector.