SIO2 MEDICAL PRODUCTS INC — Department of Defense SBIR Phase II: CBD202-003

Description

Autoinjectors are a critical piece of medical countermeasure equipment for the general public and our nation’s warfighters. Autoinjectors are used to deliver injectable drugs at home or in the field. Injectable drugs are typically packaged in traditional glass primary containers that are assembled into the auto-injector. Unfortunately, the glass autoinjector containers in use today are at risk of cracking due to tensile stress on the container, which compromises the integrity of the autoinjector and renders it unusable. These failures compromise the lifesaving measures that depend on autoinjectors, and lead to significantly increased procurement costs due to breakage that occurs throughout the supply chain. SiO2 Materials Science (SiO2) is a U.S. advanced medical technology company that produces high-performance, durable, glass-equivalent primary containers that are uniquely designed to store, transport, and protect drugs, including those that require cold-chain storage. SiO2’s primary containers are wholly manufactured in the United States and are the only available glass-equivalent alternative to traditional Type I borosilicate glass. SiO2’s hybrid container technology, which is a combination of glass and plastic, would provide a more reliable, safe, and durable autoinjector container to be used both by the military and commercially. SiO2’s shatterproof autoinjector container would also provide cost-efficiencies to the U.S. Department of Defense and pharmaceutical manufacturers during the manufacturing, filling, shipment, and deployment processes. SiO2 also creates efficiencies by preventing loss of doses and harm to patients due to detectable contamination. SiO2 has extensive experience developing and manufacturing both custom and ISO standard ready-to-use (RTU) primary containers, including vials, cartridges, and pre-filled syringes for injectable drugs. SiO2 is proud to have partnered with the U.S. Department of Defense JPEO-CBRND and HHS BARDA on the COVID-19 emergency response. In June 2020, SiO2 received $143 million from the U.S. Government and an additional $64 million commitment in August 2021 to reach an annual production capacity of 120,000,000 million vials. SiO2’s vertically-integrated manufacturing process is inherently scalable and employs fully automated lines and semi-autonomous lines with real-time 100% process monitoring and inspection. Additionally, SiO2’s manufacturing process is capable of achieving better than Six Sigma quality for critical defects. Given SiO2’s experience and current capabilities, the company is well-positioned to support the Department of Defense in its critical effort to provide safe, reliable, inert, shatterproof autoinjector containers. SiO2’s ability to provide both custom and ISO standard container solutions allows the company to support the dimensional requirements of all Department of Defense autoinjectors and ensure compatibility to increase effectiveness when used by the warfighter.