NovaSterilis, located in Ithaca, NY, is a company focused on supporting regenerative medicine manufacturers by processing (e.g., cleaning, sterilizing, impregnating, and improving) materials with supercritical carbon dioxide. The benefits of the process to manufacturers are numerous, but a key advantage is the ability to clean or sterilize matrices without destroying the biological attributes that make these materials so effective.
“NovaSterilis recognizes our greatest impact will come if we can help enable regenerative medicine pioneers to bring their products to market in a cost-effective manner. Patients expect sterile products and this expectation cannot be minimized even in light of the lofty goal of eliminating disease. This is what we learned as we brought supercritical CO2 processing to the tissue bank industry in 2010 and it is what we see playing out before us in 2019 in regenerative medicine,” explained Tony Eisenhut, CEO of NovaSterilis.
“Our work in tissue banking yielded some interesting clinical outcomes that were associated with microbial-free, mechanically enhanced donor tissue that retained critical bioactive known to be important in the healing processes. This experience has provided our team with a multi-disciplinary understanding of infection control, cleaning/decellularization, materials performance, manufacturing methods, regulatory expectations, and clinical acceptance,” continued Eisenhut.
Although NovaSterilis has market acceptance of its production-scale Nova2200 system as a preferred method of sterilization and cleaning for allograft and xenograft matrices in the tissue banking industry, the recently introduced, benchtop NovaGenesis system is likely to be the more impactful platform for ARMI members looking to advance solutions through the R&D process. The NovaGenesis supercritical CO2 system will enable research teams to develop materials and processes that can scale from the lab to manufacturing. Ultimately, the R&D work with the NovaGenesis will easily transfer to production systems, such as the Nova2200 and Nova8800.
“At our core, NovaSterilis is a team of knowledgeable, caring scientists, engineers, and business people committed to tackling difficult customer challenges through clear communication and rigorous analysis,” said Eisenhut, adding, “We have seen that supercritical CO2 can offer an alternative to ethylene oxide sterilization, which not only negatively impacts bio-based materials but it is also facing environmental regulatory challenges that have caused significant disruption to the sterilization market.”
“Our supercritical CO2process has a number of value propositions for regenerative medicine manufacturing, including: cleaning at a microstructure level, rendering matrices more valuable; disinfecting and/or sterilizing matrices, reducing the incidence of lost product due to supply source contamination; impregnation of bioactive into devices in a uniform manner; functionalization of certain materials and structures through pressurization and depressurization control; and terminal sterilization to a sterility assurance level (SAL) of 10-6,” Eisenhut explained.
When asked to look into the regenerative medicine crystal ball for the future, Eisenhut noted, “we see nothing but growth for the industry—the stage is set for major advancements that will truly impact patients’ lives. We believe the NovaSterilis platform will support this growth through its dual functions of both effecting and preserving materials and their desired performance. Having a low temperature, deep penetrating, minimally reactive process that harnesses the unique attributes of supercritical CO2, allows us to develop custom process protocols that pave a path to regulatory approval and scalable manufacturing methods ultimately with the benefit of improved patient safety and clinical outcomes.
When asked who NovaSterilis is in the regenerative medicine industry, Eisenhut replied, “we may not be the technology that captures your attention at first glance, but when you really start talking about the commercial path forward, we are a foundational technology platform that will make impactful contributions. We understand our position as a role player in the industry providing support to high-profile platforms like 3D bioprinting. We are proud to contribute to the industry and relish our role in it.”