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Production of hyperimmune anti-SARS-CoV-2 intravenous immunoglobulin from pooled COVID-19 convalescent plasma

*Author for correspondence:

E-mail Address: ali.shaukat@duhs.edu.pk

https://orcid.org/0000-0002-6513-2560

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

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Syed M Uddin

Dow College of Biotechnology, Dow University of Health Sciences, Karachi, Pakistan

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Ayesha Ali

Dow College of Biotechnology, Dow University of Health Sciences, Karachi, Pakistan

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Fatima Anjum

Dow Research Institute of Biotechnology & Biomedical Sciences, Dow University of Health Sciences, Karachi, Pakistan

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Rashid Ali

Dow College of Biotechnology, Dow University of Health Sciences, Karachi, Pakistan

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Elisha Shalim

Dow College of Biotechnology, Dow University of Health Sciences, Karachi, Pakistan

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Mujtaba Khan

Dow College of Biotechnology, Dow University of Health Sciences, Karachi, Pakistan

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Iqra Ahmed

Dow College of Biotechnology, Dow University of Health Sciences, Karachi, Pakistan

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Sheikh M Muhaymin

Dow College of Biotechnology, Dow University of Health Sciences, Karachi, Pakistan

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Uzma Bukhari

Dow International Medical College, Dow University of Health Sciences, Karachi, Pakistan

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Shobha Luxmi

Dow University Hospital, Dow University of Health Sciences, Karachi, Pakistan

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Abdul S Khan

National Control Laboratory for Biologicals, Islamabad, Pakistan

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Saeed Quraishy

Dow University of Health Sciences, Karachi, Pakistan

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Published Online:9 Feb 2021https://doi.org/10.2217/imt-2020-0263

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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 (NCT 04521309).

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Vol. 13, No. 5

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History

Received 26 September 2020

Accepted 28 January 2021

Published online 9 February 2021

Published in print April 2021

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Supplementary data

To view the supplementary data that accompany this paper please visit the journal website at: www.futuremedicine.com/doi/suppl/10.2217/imt-2020-0263

Author contributions

S Ali was responsible for concept design, supervision, laboratory experimentation, critical analysis and drafting and finalization of the manuscript. S Uddin was responsible for process design optimization, laboratory experimentation, critical analysis and drafting and finalization of the manuscript. A Ali performed process quality control, laboratory experimentation, critical analysis and drafting and finalization of the manuscript. M Khan performed process quality control, laboratory experimentation, critical analysis and drafting of the manuscript. F Anjum and R Ali performed process design optimization, laboratory experimentation and critical analysis. E Shalim carried out laboratory experimentation, data acquisition and critical analysis. I Ahmed and U Bukhari performed laboratory experimentation and drafting of the manuscript. S Muhaymin performed laboratory experimentation and critical analysis. S Luxmi was responsible for the collection of raw material and addressed clinical needs. A Khan provided expert advice and was responsible for process design approval and finalization of the manuscript. S Quraishy was responsible for concept design, process design approval and finalization of the manuscript.

Financial & competing interests disclosure

The authors received funding from Dow University of Health Sciences and Higher Education Commission Pakistan grant number: 20-RRG-134/RGM/R&D/HEC/2020. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Ethical conduct of research

The authors state that they have obtained appropriate institutional review board approval for animal experimental investigations. Ref IRB-1685/DUHS/Approval/2020/79. The animals used in this study were maintained in accordance to the ethical guidelines of Dow University of Health Sciences, Karachi, Pakistan.

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