Development of a sterilization process for amniotic membrane allograft tissue using supercritical carbon dioxide and NovaKill.

Abstract

Amniotic membrane is arguably one of the most popular biological wound dressings on the market today. Various growth factors and cytokines inherent to amniotic membrane tissue have been recognized as key mediators in wound healing and tissue regeneration, giving the tissue its clinical utility. Sterilization methodologies using irradiation are recognized as the gold standard in the field and routinely used to prepare tissue allografts, including amniotic membrane for transplantation. However, irradiation is not always compatible in preserving the physical structure or biochemical factors of biological materials and can potentially result in detrimental effects to the critical quality attributes of allograft tissues. Alternatively, a novel sterilization technique involving supercritical carbon dioxide (SCCO₂) has been shown to have minimal effect on the inherent biophysical properties of sensitive biological tissues and tissue-derived products. At BioBridge Global, we have developed a process utilizing SCCO₂ technology for the sterilization of an amniotic membrane tissue allograft product. This process, first and foremost, meets industry standards for sterilization while simultaneously maintaining the biochemical composition of the tissue. Our results show that upon SCCO₂ sterilization, most of the growth factors tested were conserved, with many at quantities significantly greater than commercially available gamma and electron beam irradiated tissue. The SCCO₂-sterilized amniotic membrane allograft is unique in that it is designed to overcome limitations associated with traditional tissue sterilization methodologies, namely, the conservation of key biological factors inherent to native amniotic membrane tissue. It is anticipated that by retaining these biological factors, clinical outcomes associated with the use of SCCO₂-sterilized amniotic membrane will be improved.