There is a growing number of "Biologic Materials" being used in medicine. The fields of bioengineering and tissue engineering are responsible for the availability of new medical devices that contain natural, synthetic or combination products that in some cases assist the body to heal or regenerate tissue. NovaSterilis’s SCCO2 sterilization process has been utilized to sterilize innovative regenerative materials, polymers, and biologic scaffolds, resulting in sterilization with little or no effect on the material.
The list of these materials and the combinations continues to grow. This section covers extra cellular matrices, collagen scaffolds, polymers in many forms, allograft materials, xenograft or animal-derived materials, and man-made materials. Scroll down to explore each of these in more detail.
As these products become more technical and refined, it becomes vital to utilize a sterilization process that maintains the physical characteristics and biologic qualities of the material being sterilized. The desire to produce materials that quickly integrate and support stem cell attachment and proliferation will limit your sterilization choices; NovaSterilis has a growing data set that supports SCCO2 sterilization for these materials providing sterilization without degradation of the material.
Xenograft or Animal-Derived Material
One of the fastest growing segments of this category is xenograft tissue. These tissues can originate from bovine (cow), porcine (pig), ovine (sheep), and other non-human species. They come in many different forms including powders, sheets, tubes, and gels, all of which are chosen to meet highly specific needs. The list of currently marketed materials includes, but is not limited to; acellular dermis, bovine and porcine pericardium, fascia, porcine small intestine submucosa, bladder, heart valves and pure collagen.
Current research is focused on finding new uses for these materials and fine tuning them to improve clinical outcomes. Acellular dermis has a long history of abdominal wall repair but the product is also used for breast reconstruction and plastic surgery. Porcine small intestine submucosa (SIS) is widely applied in surgery and regenerative medicine with applications ranging from wound care to cardiac repair. Since many of these products are primarily used as surgical implants, sterilization is extremely important to protect patients and ensure successful surgical outcomes.
As researchers continue to fine tune material properties and explore the mechanism by which these materials work, it is becoming clear that sterilization with ethylene oxide, steam, and radiation have negative effects on the material and its ability to support stem cell proliferation. Multiple papers have shown that supercritical carbon dioxide sterilization is superior for many of these materials1,2,3. At NovaSterilis, our goal is to assist you to produce a final product that most closely matches the material prior to sterilization. At NovaSterilis, we don’t believe that you must decide between sterility and performance, and the volume of evidence is growing to support NovaSterilis SCCO2 sterilization for biomaterials.
Within the biomaterials segment there is a growing use of natural or biopolymers and synthetic polymers. The ability to tune polymer materials and new ways of processing these biopolymers, for example electro spinning, is providing new opportunities to create specialized products. These new materials and processes are driving innovation and creating innovative solutions to difficult medical issues.
There are many biopolymers commercially available; collagen, chitosan and alginates are among the most popular. Some biopolymers including collagen and alginates are very sensitive to heat and experience significant changes during sterilization, resulting in poor product performance. NovaSterilis SCCO2 sterilization has been successfully used to sterilize collagen and alginates without detrimental effects to the product.
NovaSterilis also has successfully sterilized many synthetic or commercial polymers, most notably completing a NIH Phase ll grant for the sterilization of absorbable sutures. We utilized absorbable sutures as a surrogate since these products are well characterized and readily available. The work completed showed that not only could we sterilize the sutures and maintain the structural and mechanical characteristics, but also that the NovaSterilis process produced a suture that was less cytotoxic than current commercial sutures. In addition, this study provided additional data that led to a patent for the removal of residual ethylene oxide from devices and materials.
Supercritical carbon dioxide has many other applications in the manufacture of polymers. NovaSterilis has experience with foaming some CO2 soluble polymers.
If you have, or are developing a product that needs to maintain physical or biochemical properties, or wish to use a more environmentally friendly process, please contact us to perform testing on your material. NovaSterilis is proud to be partnering with a number of leaders in the tissue engineering and regenerative medical community.
1. RESEARCH ARTICLE Improved Sterilization of Sensitive Biomaterials with Supercritical Carbon Dioxide at Low Temperature
Anne Bernhardt1*, Markus Wehrl2, Birgit Paul1, Thomas Hochmuth2, Matthias Schumacher1, Kathleen Schütz1, Michael Gelinsky1,
1 Centre for Translational Bone, Joint and Soft Tissue Research, Medizinische Fakultät, Technische Universität Dresden, Dresden, Germany, 2 wfk—Cleaning Technology Institute e.V., Krefeld, Germany)
2. Development of a Sterile Amniotic Membrane Tissue Graft Using Supercritical Carbon Dioxide
Jennifer L. Wehmeyer, PhD, Shanmugasundaram Natesan, PhD, and Robert J. Christy, PhD
TISSUE ENGINEERING: Part C
Volume 00, Number 00, 2015
3. Inactivation of Bacterial Spores and Viruses in Biological Material Using Supercritical Carbon Dioxide With Sterilant
Qing-Qing Qiu, Patrick Leamy, Jennie Brittingham, Jason Pomerleau, Nimesh Kabaria, Jerome Connor
Department of Research, LifeCell Corporation, Branchburg, New Jersey 08876
Received 10 December 2008; revised 25 March 2009; accepted 15 April 2009