O'Connell Jennifer, Pentakota Komali, Villeareal Donny, Faz Jose, Li Xiaoli, Trinh Anthony, Beddard Rachel, Jones Scott, Srinivasan Anand
The Center for Innovations and Biodesign, San Antonio, TX, USA.
BioBridge Global, Research and Development, San Antonio, TX, USA.
Cell Tissue Bank. 2024 Dec 16;26(1):4. doi: 10.1007/s10561-024-10152-1.
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 (SCCO) 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 SCCO 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 SCCO 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 SCCO-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 SCCO-sterilized amniotic membrane will be improved.
羊膜可以说是当今市场上最受欢迎的生物伤口敷料之一。羊膜组织中固有的各种生长因子和细胞因子已被公认为伤口愈合和组织再生的关键介质，赋予了该组织临床应用价值。使用辐照的灭菌方法被认为是该领域的金标准，并且通常用于制备同种异体组织移植，包括用于移植的羊膜。然而，辐照并不总是与保存生物材料的物理结构或生化因子兼容，并且可能对同种异体移植组织的关键质量属性产生不利影响。另外，一种涉及超临界二氧化碳（SCCO）的新型灭菌技术已被证明对敏感生物组织和组织衍生产品的固有生物物理特性影响最小。在BioBridge Global公司，我们已经开发出一种利用SCCO技术对羊膜组织同种异体移植产品进行灭菌的工艺。这个工艺首先满足了行业的灭菌标准，同时保持了组织的生化组成。我们的结果表明，经过SCCO灭菌后，大多数测试的生长因子得以保留，其中许多生长因子的含量明显高于市售的伽马射线和电子束辐照组织。经SCCO灭菌的羊膜同种异体移植产品的独特之处在于，它旨在克服与传统组织灭菌方法相关的局限性，即保留天然羊膜组织固有的关键生物因子。预计通过保留这些生物因子，使用经SCCO灭菌的羊膜的临床效果将会得到改善。
