Shaukat Ali1,2, Syed M Uddin1, Ayesha Ali1, Fatima Anjum2, Rashid Ali1, Elisha Shalim1, Mujtaba Khan1, Iqra Ahmed1, Sheikh M Muhaymin1, Uzma Bukhari3, Shobha Luxmi4, Abdul S Khan5, Saeed Quraishy6. 1. Dow College of Biotechnology, Dow University of Health Sciences, Karachi, Pakistan. 2. Dow Research Institute of Biotechnology & Biomedical Sciences, Dow University of Health Sciences, Karachi, Pakistan. 3. Dow International Medical College, Dow University of Health Sciences, Karachi, Pakistan. 4. Dow University Hospital, Dow University of Health Sciences, Karachi, Pakistan. 5. National Control Laboratory for Biologicals, Islamabad, Pakistan. 6. Dow University of Health Sciences, Karachi, Pakistan.
Abstract
Background: 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. Materials & methods: PCP was fractionated by modified caprylic acid precipitation followed by ultrafiltration/diafiltration to produce hyperimmune C-IVIG. Results: 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. Conclusion: 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).
Background: 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. Materials & methods: PCP was fractionated by modified caprylic acid precipitation followed by ultrafiltration/diafiltration to produce hyperimmune C-IVIG. Results: 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. Conclusion: 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).
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