The objectives of the Phase II research are to develop a simple and cost-effective method for large-scale production of anti-microbial N95 respirator masks. The work proposed will accomplish the necessary steps to scale our production of a Light Activated Anti Microbial (LAAM) fabric coating to manufacturing. Significance: Influenza and other enveloped viruses are responsible for hundreds of thousands of deaths worldwide each year and cost the US economy over $70 billion each year in medical costs and lost work. A new approach to preventing the spread of viral infections in general, and influenza in particular, would be of benefit. Influenza enters the body through the nose or throat. As a precaution, to themselves and patients, caregivers wear personal protective equipment (PPE) such as a respirator masks to minimize contact transmission onto facial skin or airborne inhalation of pathogenic organisms. Case-control studies conducted in Beijing and Hong Kong showed that wearing masks in public was independently associated with protection from SARS in a multivariate analysis. However, a study performed by the CDC showed definitive evidence of the transmission of virus particles from PPE to other people and surfaces in a hospital setting. Thus, opportunities exist for simple, efficacious decontamination methods that reduce the risk of infection through handling a contaminated respirator and that do not compromise respirator effectiveness. Approach: The LaamScience, Inc. (LSI) value proposition is that a mask with the LSI antimicrobial coating on its surface is self decontaminating and will reduce the risk of transmission to the wearer, to other people, and to other surfaces. Innovation: Using our proprietary technology, LSI is developing antimicrobial coatings useful for a durable, self-decontaminating, and cost effective N95 respirator mask with a broad spectrum of viral inactivation. Importantly, the mechanism of inactivation will not lead to microbial resistance. We are developing a non-leaching fiber treatment binding photoactive dyes that inactivate viruses upon illumination with conventional lighting. Candidate dyes have been chosen that generate the most singlet oxygen [the active antiviral agent] per unit light intensity for light sources simulating solar, incandescent, and fluorescent lighting. In the Phase I portion of this grant, we established efficacy against influenza virus and Staphylococcal bacteria in light intensities equivalent to typical hospital room lighting and >99.9% microbial inactivation in less than an hour. We also completed physical integrity testing, bench testing and performance testing for submission of the N95 mask for NIOSH certification.
The Specific Aims for this Phase II project are to: 1) Continue refinements of the antiviral chemistry used in fabrics to increase antiviral activity and to aid in the large scale production of antiviral fabrics at a commercially feasible scale and cost. 2) Build a pilot plant for fabric manufacture and generate a validation manufacturing plan. 3) Demonstrate that the optimized antiviral coatings on the filtration medium do not interfere with the ease of use, fit and comfort characteristics of the mask/respirator.
Influenza spreads rapidly throughout the world in seasonal epidemics. The World Health Organization estimates that influenza epidemics cost the US economy $71-167 billion per year and that 250,000-500,000 people die every year from influenza epidemics. Influenza enters the body through the nose or throat. Groups most at risk are health care workers, hospital patients, and the young and geriatric population. In closed settings, [e.g., hospitals, child-care centers, military barracks, college dormitories, nursing homes] infections spread rapidly. Masks and respirators are intended to reduce the wearer's exposure to small airborne particles including bacteria, fungi, and viruses. The goal of the research is to transition the manufacture of antiviral fabric and respirator masks from the test lab to large-scale manufacturing.