Dow College of Biotechnology, Dow University of Health Sciences, Karachi, Pakistan.
Dow Research Institute of Biotechnology & Biomedical Sciences, Dow University of Health Sciences, Karachi, Pakistan.
Immunotherapy. 2021 Apr;13(5):397-407. doi: 10.2217/imt-2020-0263. Epub 2021 Feb 9.
This study assesses the feasibility of producing hyperimmune anti-COVID-19 intravenously administrable immunoglobulin (C-IVIG) from pooled convalescent plasma (PCP) to provide a safe and effective passive immunization treatment option for COVID-19. PCP was fractionated by modified caprylic acid precipitation followed by ultrafiltration/diafiltration to produce hyperimmune C-IVIG. In C-IVIG, the mean SARS-CoV-2 antibody level was found to be threefold (104 ± 30 cut-off index) that of the PCP (36 ± 8.5 cut-off index) and mean protein concentration was found to be 46 ± 3.7 g/l, comprised of 89.5% immunoglobulins. The current method of producing C-IVIG is feasible as it uses locally available PCP and simpler technology and yields a high titer of SARS-CoV-2 antibody. The safety and efficacy of C-IVIG will be evaluated in a registered clinical trial (NCT04521309).
本研究评估了从恢复期血浆（PCP）中制备高免疫抗 COVID-19 静脉内可给予免疫球蛋白（C-IVIG）的可行性，以提供 COVID-19 的安全有效被动免疫治疗选择。PCP 通过改良的辛酸沉淀然后超滤/渗滤进行分级，以产生高免疫 C-IVIG。在 C-IVIG 中，SARS-CoV-2 抗体水平平均为 PCP 的三倍（104±30 截止指数）（36±8.5 截止指数），平均蛋白浓度为 46±3.7g/l，由 89.5%的免疫球蛋白组成。目前生产 C-IVIG 的方法是可行的，因为它使用了本地可用的 PCP 和更简单的技术，并产生了高滴度的 SARS-CoV-2 抗体。C-IVIG 的安全性和有效性将在一项注册临床试验（NCT04521309）中进行评估。
