Grifols Bioscience Research & Development, Scientific Innovation Office, 85 TW Alexander Drive, Research Triangle Park, NC 27709, USA.
Epidemiol Infect. 2022 Sep 13;150:e172. doi: 10.1017/S095026882200142X.
While tetanus toxoid vaccination has reduced the incidence of tetanus in the developed world, this disease remains a substantial health problem in developing nations. Tetanus immune globulin (TIG) is used along with vaccination for prevention of infection after major or contaminated wounds if vaccination status cannot be verified or for active tetanus infection. These studies describe the characterisation of a TIG produced by a caprylate/chromatography process. The TIG potency and presence of plasma protein impurities were analysed at early/late steps in the manufacturing process by chromatography, immunoassay, coagulation and potency tests. The caprylate/chromatography process has been previously shown to effectively eliminate or inactivate potentially transmissible agents from plasma-derived products. In this study, the caprylate/chromatography process was shown to effectively concentrate TIG activity and efficiently remove pro-coagulation factors, naturally present in plasma. This TIG drug product builds on the long-term evidence of the safety and efficacy of TIG by providing a product with higher purity and low pro-coagulant protein impurities.
虽然破伤风类毒素疫苗接种已经降低了发达国家破伤风的发病率，但这种疾病在发展中国家仍然是一个严重的健康问题。破伤风免疫球蛋白（TIG）与疫苗接种一起用于预防重大或污染性伤口后的感染，如果无法核实疫苗接种状态或存在破伤风感染。这些研究描述了一种通过辛酸/层析工艺生产的 TIG 的特性。通过层析、免疫测定、凝固和效价试验，在制造过程的早期/晚期分析 TIG 的效价和血浆蛋白杂质的存在。辛酸/层析工艺已被证明可有效地从血浆衍生产品中去除或灭活潜在的可传播剂。在这项研究中，辛酸/层析工艺被证明可以有效地浓缩 TIG 活性，并有效地去除天然存在于血浆中的促凝血因子。该 TIG 药物产品建立在 TIG 的长期安全性和疗效证据的基础上，提供了一种更高纯度和低促凝血蛋白杂质的产品。
