Validation of Viral Inactivation/ Elimination Protocols for Therapeutic Blood Products (TBP) against Emerging and Re-emerging Viruses: Specific Cases of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-Cov-2) and Ebolaviruses (EBOV)

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Title:	Validation of Viral Inactivation/ Elimination Protocols for Therapeutic Blood Products (TBP) against Emerging and Re-emerging Viruses: Specific Cases of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-Cov-2) and Ebolaviruses (EBOV)
Authors:	BELEM, WENDIMI FATIMATA
Contributors:	��ڥ��u�{�դh�Ǧ�ǵ{ BURNOUF, THIERRY LIN, LIANG-TZUNG
Keywords:	SARS-CoV-2;Ebolavirus;COVID-19/Ebolavirus disease convalescent plasma/serum;neutralizing antibodies;Pathogen reduction technology
Date:	2023-06-15
Issue Date:	2023-12-07 09:54:01 (UTC+8)
Abstract:	Introduction Convalescent plasma (CP) or concentrated immunoglobulin (Ig) preparations have been used in the COVID-19 pandemic and the different Ebolavirus (EBOV) disease (EVD) outbreaks as a possible prophylactic or therapeutic option. However, blood product therapy presents pathogen safety issues that need to be addressed to support the safety of the therapy. Several pathogen reduction technologies including solvent/detergent (S/D) treatments have been engineered and applied to plasma for transfusion to provide a significant assurance of viral safety. Additionally, several viral inactivation/removal methods including nanofiltration, have been engineered and implemented in the production process of Igs. Aims The goal of this Ph.D. research work is to evaluate: (1) the impact of S/D [S: 1% Tri-n-butyl phosphate (TnBP) and D: 1% TritonX-100 or 1% TritonX-45)] treatments of plasma on SARS-CoV-2 infectivity and on the functional neutralizing activity of SARS-CoV-2 Abs in COVID-19 convalescent plasma and (2) the impact of Planova 35N nanofilters on the removal of EBOV infectivity and ability of Abs to neutralize EBOV in human Ig solutions. Materials and methods The SARS-CoV-2 pseudovirus (SARS-CoV-2pp) and EBOV-like particles (EBOV VLP) were produced by transfection of HEK293FT cells. The S/D treatments of plasma were done at 31�XC for 30 min followed by filtration through a Sep-Pak Plus C18 cartridge. The human IgG solution was subjected to nanofiltration according to the manufacturer's recommendation. The virus inactivation and neutralizing assay were performed by infecting Huh-7 cells. Results We successfully produced SARS-CoV-2pp and EBOV VLP as surrogate models of native viruses. The absence of toxicity in different samples was demonstrated before the infectivity assay. Complete inactivation of SARS-CoV-2pp (over 4Log10) and complete removal of EBOV VLP (over 3Log10) without the detection of residual virus in the products as well as the preservation of the neutralizing activity of Abs in COVID-19 convalescent serum and EVD plasma-derived polyvalent immunoglobulin models were observed after completion of both S/D treatments and Planova 35N filtration. Conclusion The major treatments and nanofiltration have been engineered to inactivate or remove viruses from CP or IgG solution and appear effective at reducing SARS-CoV-2 and EBOV without altering the neutralizing activity of their Ab content
Description:	�դh ��ɱб�:BURNOUF, THIERRY �@�P��ɱб�: LIN, LIANG-TZUNG �e��:CHUANG, ER-YUAN �e��:COGNASSE, FABRICE �e��:LIN, JING-YI �e��:BURNOUF, THIERRY �e��:LIN, LIANG-TZUNG
Data Type:	thesis
Appears in Collections:	[International Ph.D. Program in Biomedical Engineering] Thesis

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