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

被引：31

作者：

Ali, Shaukat ^{[1
,2
]}

Uddin, Syed M. ^{[1
]}

Ali, Ayesha ^{[1
]}

Anjum, Fatima ^{[2
]}

Ali, Rashid ^{[1
]}

Shalim, Elisha ^{[1
]}

Khan, Mujtaba ^{[1
]}

Ahmed, Iqra ^{[1
]}

M Muhaymin, Sheikh ^{[1
]}

Bukhari, Uzma ^{[3
]}

Luxmi, Shobha ^{[4
]}

Khan, Abdul S. ^{[5
]}

Quraishy, Saeed ^{[6
]}

机构：

[1] Dow Univ Hlth Sci, Dow Coll Biotechnol, Karachi, Pakistan

[2] Dow Univ Hlth Sci, Dow Res Inst Biotechnol & Biomed Sci, Karachi, Pakistan

[3] Dow Univ Hlth Sci, Dow Int Med Coll, Karachi, Pakistan

[4] Dow Univ Hlth Sci, Dow Univ Hosp, Karachi, Pakistan

[5] Natl Control Lab Biol, Islamabad, Pakistan

[6] Dow Univ Hlth Sci, Karachi, Pakistan

来源：

IMMUNOTHERAPY | 2021年 / 13卷 / 05期

关键词：

convalescent plasma; SARS-CoV-2; intravenous immunoglobulins; anti-COVID-19; IVIG; passive immunization; pooled plasma; caprylic acid; ultrafiltration; diafiltration; immunotherapy; PREVENTION; THERAPY;

D O I：

10.2217/imt-2020-0263

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

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).

引用

页码：397 / 407

页数：11

共 38 条

[21] Immunoglobulins in the treatment of COVID-19 infection: Proceed with caution! [J].

Nguyen, Alan A. ;

Habiballah, Saddiq B. ;

Platt, Craig D. ;

Geha, Raif S. ;

Chou, Janet S. ;

McDonald, Douglas R. .

CLINICAL IMMUNOLOGY, 2020, 216

[22] Applicability of bacterial endotoxins test to various blood products by the use of endotoxin-specific lysates [J].

Ochiai, Masaki ;

Yamamoto, Akihiko ;

Naito, Seishiro ;

Maeyama, Jun-ichi ;

Masumi, Atsuko ;

Hamaguchi, Isao ;

Horiuchi, Yoshinobu ;

Yamaguchi, Kazunari .

BIOLOGICALS, 2010, 38 (06) :629-636

[23] A modified caprylic acid method for manufacturing immunoglobulin G from human plasma with high yield and efficient virus clearance [J].

Parkkinen, J ;

Rahola, A ;

von Bonsdorff, L ;

Tölö, H ;

Törmä, E .

VOX SANGUINIS, 2006, 90 (02) :97-104

[24]

Pharmacopeia 41 U.S., 2018, US PHARM CONV INC ND, P6083

[25] Intravenous immunoglobulin G: trends in production methods, quality control and quality assurance [J].

Radosevich, M. ;

Burnouf, T. .

VOX SANGUINIS, 2010, 98 (01) :12-28

[26] The epidemiology and pathogenesis of coronavirus disease (COVID-19) outbreak [J].

Rothan, Hussin A. ;

Byrareddy, Siddappa N. .

JOURNAL OF AUTOIMMUNITY, 2020, 109

[27] Antibody therapies for the prevention and treatment of viral infections [J].

Salazar, Georgina ;

Zhang, Ningyan ;

Fu, Tong-Ming ;

An, Zhiqiang .

NPJ VACCINES, 2017, 2

[28] Treatment of 5 Critically Ill Patients With COVID-19 With Convalescent Plasma [J].

Shen, Chenguang ;

Wang, Zhaoqin ;

Zhao, Fang ;

Yang, Yang ;

Li, Jinxiu ;

Yuan, Jing ;

Wang, Fuxiang ;

Li, Delin ;

Yang, Minghui ;

Xing, Li ;

Wei, Jinli ;

Xiao, Haixia ;

Yang, Yan ;

Qu, Jiuxin ;

Qing, Ling ;

Chen, Li ;

Xu, Zhixiang ;

Peng, Ling ;

Li, Yanjie ;

Zheng, Haixia ;

Chen, Feng ;

Huang, Kun ;

Jiang, Yujing ;

Liu, Dongjing ;

Zhang, Zheng ;

Liu, Yingxia ;

Liu, Lei .

JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2020, 323 (16) :1582-1589

[29] Covid-19: FDA approves use of convalescent plasma to treat critically ill patients [J].

Tanne, Janice Hopkins .

BMJ-BRITISH MEDICAL JOURNAL, 2020, 368 :m1256

[30] Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a rapid review [J].

Valk, Sarah J. ;

Piechotta, Vanessa ;

Chai, Khai Li ;

Doreen, Carolyn ;

Monsef, Ina ;

Wood, Erica M. ;

Lamikanra, Abigail ;

Kimber, Catherine ;

McQuilten, Zoe ;

So-Osman, Cynthia ;

Estcourt, Lise J. ;

Skoetz, Nicole .

COCHRANE DATABASE OF SYSTEMATIC REVIEWS, 2020, (05)

← 1 2 3 4 →