On-Orbit Solution Recycling Methods to Improve Scale of Layer-by-Layer Artificial Retina Manufacturing

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 artificial retina thin films 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 deposited onto an ion-permeable film. LambdaVision is leveraging the unique properties of microgravity that allow for more ordered and consistent three-dimensional assembly of the protein and polymer layers. The microgravity environment has the potential to improve the quality of the films, reduce defects, and enhance the stability and performance of the artificial retinas for future preclinical and clinical trials. In collaboration with Space Tango, LambdaVision has completed a series of proof-of-principle microgravity experiments that have established a foundation for producing artificial retinas using a low-Earth orbit (LEO) platform. This effort led to the optimization of a fluidic chamber LBL manufacturing device, though further steps are required to improve the scale for commercial production. The Phase I research strategy involved enhancing the precision of quantification methods for polyion solutions, developing effective filtration methods, optimizing UV-C sterilization for bioburden reduction, and establishing in situ analytical tools to assess solution quality. Building on these results, this Phase II work plan will integrate these advancements into a closed-loop system for efficient, sustainable LBL manufacturing that will improve scale, reduce up-mass raw materials, and reduce waste. The deliverables will add new on-orbit tools to the established LBL manufacturing platform, and solution recycling techniques will ensure that artificial retina production can be achieved at an increased scale on the ISS or future commercial LEO destination. 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 artificial retina thin films 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 deposited onto an ion-permeable film. Because uniform orientation and layer homogeneity of the multilayered implant is critical for achieving activity and long-term performance, LambdaVision is leveraging the unique properties of microgravity that allow for more ordered and consistent three-dimensional assembly of the protein and polymer layers. The microgravity manufacturing paradigms have the potential to improve the quality of the films, reduce intralayer defects, and, as a result, enhance the stability and performance of the artificial retinas for future preclinical and clinical trials. This Phase II SBIR proposal represents critical research and development activities that will help to develop on-orbit capabilities that can improve implementation and scaling of artificial retina manufacturing in LEO. This research strategy includes the use of the recycling of bulk solutions to be utilized in multiple LBL manufacturing cycles, which would allow for a significant increase in manufacturing capacity and a reduction of waste. This approach not only conserves valuable resources, but also sets a precedent for sustainable practices in biomedical manufacturing in microgravity. In this Phase II proposal, we will utilize terrestrial-based efforts to achieve the following objectives: (1) refine methods to purify, sterilize, and analyze LBL solutions; (2) optimize fluidic handling and software required to support manufacturing integration, (3) evaluate recycling efficiency and quality of artificial retinas, and (4) assess requirements for integration with LEO platforms.   Deliverables: Complete benchtop modules required for solution recycling Key elements of fluidic handling and software required for integration in a LBL manufacturing system A functional LBL manufacturing system with integrated recycling modules A final report that summarizes science requirements and operations for implementation in LEO A preliminary project scope/schedule for Phase III

The outcomes of the proposed Phase II SBIR work plan will optimize the use of raw materials in microgravity and will yield critical hardware components that can support efficient, sustainable, and scalable manufacturing methods for LambdaVisoin’s artificial retina technology. Moreover, the purification, sterilization, and analytical techniques established in this research will provide new tools for integrating biomaterials as components for in-space production of forthcoming terrestrial-based applications. This work establishes capabilities to support commercial artificial retina production in LEO. However, the developed techniques can be adapted for many biomedical applications, including drug delivery, tissue engineering, and beyond.  Strategies to improve scale, control raw material consumption, and improve unit economics will inspire new in-space production opportunities across multiple fields.

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