by Douglas Messier
People with failing eye sight could see their vision restored with the help of NASA-funded research aboard the International Space Station (ISS).
The space agency has selected LamdaVision for a small business award to continue development of a system to manufacture protein-based retinal implants aboard the space station.
The Small Business Innovation Research (SBIR) phase II award is worth up to $750,000 over two years. NASA previously supported the project with a smaller SBIR phase I grant.
“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,” LamdaVision said in its proposal summary.
“However, the current terrestrial LBL approach is influenced by gravity, in which sedimentation and gradients of solutions interfere with the quality of the implants,” the summary added.
LamdaVision, of Farmington, Conn., said it has conducted trail manufacturing aboard ISS that showed the microgravity conditions there eliminate the flaws caused by gravity.
The SBIR phase II grant will allow the company to produce a LBL prototype and conduct additional research.
The project summary follows.
Implementation of a Layer-by-Layer Manufacturing Apparatus for the Assembly of Protein-Based Retinal Implants in Low Earth Orbit
Subtopic: Low Earth Orbit Platform Utilization and Microgravity Research
Estimated Technology Readiness Level (TRL) :
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 non-clinical 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 NASA’s strategic plan for commercialization in LEO to build a sustainable production pipeline for this technology and for forthcoming technologies in the biomedical sector.
Potential NASA Applications
This Phase II SBIR establishes the capabilities required to support LEO commercialization of protein-based retinal implants. The implant targets patients with retinal degeneration, a leading cause of blindness for millions around the globe, including astronauts exposed to extended-duration spaceflight.
The work outlined will support a new sector in the Space economy, which utilizes the impact of microgravity on physical systems to improve current production methods for patient therapies.
Potential Non-NASA Applications
An enhanced layer-by-layer manufacturing process can improve the homogeneity, orientation, and stability of multilayered thin films for broad applications, including retinal implants, 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.
Duration: 24 months