The Clearant Process® is a broad based sterilization platform which takes advantage of the inherent scalability, availability and consistency of ionizing radiation. In addition to sterilization of tissue allografts, Clearant intellectual property (IP) portfolio includes potential applications to biological and synthetic materials and chemicals which require sterilization. These potential applications are not used in full scale production now and range from conceptual to "ready to implement." Some of these potential applications could include…

• Combination products: Combination products are the combination of drugs and medical devices or biologics.
  
  
• DBM and tissue derivatives: These include tissue derivatives with a low risk of viral contamination, such as Demineralized Bone Matrix (DBM). This material could be packaged in either a vial or pre-filled syringe format and would be sterile. DBM is commonly used on dental implants and as bone filler.
  
  
• Plasma Protein Therapeutics: the plasma industry develops and manufactures plasma protein therapeutic products which are mainly derived by the fractionation of human plasma. Potential applications include intravenous immunoglobulin (IgIV), factor VIII and albumin. The Clearant Process® may have the ability to permit practical terminal sterilization in the vial: Something we believe no current commercial method can achieve.
  
  
• Raw materials for research and pharmaceutical manufacturing: Materials such as fetal calf serum are imported from countries certified free of mad-cow disease, but which have the potential of other contaminants, such as foot and mouth disease. These materials are often used to nourish cell cultures used in the manufacture of vaccines and other materials. The Clearant Process® is believed to have the potential to protect components in the serum from damage by the radiation.
  
  
• Synthetic materials: Some polymers weaken substantially from exposure to gamma radiation, even after the application of antioxidants (e.g.: polypropylene homopolymer). Combination of an optimized protectant package with proprietary sterilization techniques lowers the damage to the polymers.
  
  
• Recombinant drug and diagnostic products from the biotechnology industry such as insulin, erythropoietin, monoclonal antibodies and bone morphogenic protein (BMP) have applications in drugs, medical devices and additives. These genetically engineered materials, many still in development stages, may be terminally sterilized by the Clearant Process®. Contact us to learn about working with us during your development process to optimize parameters to your specific application to achieve terminal sterilization.
  
  
• Potential applications of the Clearant platform with bulk industrial mixtures where biological contamination is a problem, such as process intermediates, slurries and natural feedstocks which require bioburden reduction and preservation of enzymatic activity and/or chemical structure might be possible using Clearant IP and technology.