In vitro Characterization of Anti-SARS-CoV-2 Intravenous Immunoglobulins (IVIg) Produced From Plasma of Donors Immunized With the BNT162b2 Vaccine and Its Comparison With a Similar Formulation Produced From Plasma of COVID-19 Convalescent Donors
Despite vaccines are the main strategy to control the ongoing global COVID-19 pandemic, their effectiveness could not be enough for individuals with immunosuppression. In these cases, as well as in patients with moderate/severe COVID-19, passive immunization with anti-SARS-CoV-2 immunoglobulins coul...
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| Published in | Frontiers in medical technology Vol. 3; p. 772275 |
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| Main Authors | , , , , , , , , , , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
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Switzerland
Frontiers Media S.A
05.01.2022
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| Abstract | Despite vaccines are the main strategy to control the ongoing global COVID-19 pandemic, their effectiveness could not be enough for individuals with immunosuppression. In these cases, as well as in patients with moderate/severe COVID-19, passive immunization with anti-SARS-CoV-2 immunoglobulins could be a therapeutic alternative. We used caprylic acid precipitation to prepare a pilot-scale batch of anti-SARS-CoV-2 intravenous immunoglobulins (IVIg) from plasma of donors immunized with the BNT162b2 (Pfizer-BioNTech) anti-COVID-19 vaccine (VP-IVIg) and compared their
in vitro
efficacy and safety with those of a similar formulation produced from plasma of COVID-19 convalescent donors (CP-IVIg). Both formulations showed immunological, physicochemical, biochemical, and microbiological characteristics that meet the specifications of IVIg formulations. Moreover, the concentration of anti-RBD and ACE2-RBD neutralizing antibodies was higher in VP-IVIg than in CP-IVIg. In concordance, plaque reduction neutralization tests showed inhibitory concentrations of 0.03–0.09 g/L in VP-IVIg and of 0.06–0.13 in CP-IVIg. Thus, VP-IVIg has
in vitro
efficacy and safety profiles that justify their evaluation as therapeutic alternative for clinical cases of COVID-19. Precipitation with caprylic acid could be a simple, feasible, and affordable alternative to produce formulations of anti-SARS-CoV-2 IVIg to be used therapeutically or prophylactically to confront the COVID-19 pandemic in middle and low-income countries. |
|---|---|
| AbstractList | Despite vaccines are the main strategy to control the ongoing global COVID-19 pandemic, their effectiveness could not be enough for individuals with immunosuppression. In these cases, as well as in patients with moderate/severe COVID-19, passive immunization with anti-SARS-CoV-2 immunoglobulins could be a therapeutic alternative. We used caprylic acid precipitation to prepare a pilot-scale batch of anti-SARS-CoV-2 intravenous immunoglobulins (IVIg) from plasma of donors immunized with the BNT162b2 (Pfizer-BioNTech) anti-COVID-19 vaccine (VP-IVIg) and compared their
in vitro
efficacy and safety with those of a similar formulation produced from plasma of COVID-19 convalescent donors (CP-IVIg). Both formulations showed immunological, physicochemical, biochemical, and microbiological characteristics that meet the specifications of IVIg formulations. Moreover, the concentration of anti-RBD and ACE2-RBD neutralizing antibodies was higher in VP-IVIg than in CP-IVIg. In concordance, plaque reduction neutralization tests showed inhibitory concentrations of 0.03–0.09 g/L in VP-IVIg and of 0.06–0.13 in CP-IVIg. Thus, VP-IVIg has
in vitro
efficacy and safety profiles that justify their evaluation as therapeutic alternative for clinical cases of COVID-19. Precipitation with caprylic acid could be a simple, feasible, and affordable alternative to produce formulations of anti-SARS-CoV-2 IVIg to be used therapeutically or prophylactically to confront the COVID-19 pandemic in middle and low-income countries. Despite vaccines are the main strategy to control the ongoing global COVID-19 pandemic, their effectiveness could not be enough for individuals with immunosuppression. In these cases, as well as in patients with moderate/severe COVID-19, passive immunization with anti-SARS-CoV-2 immunoglobulins could be a therapeutic alternative. We used caprylic acid precipitation to prepare a pilot-scale batch of anti-SARS-CoV-2 intravenous immunoglobulins (IVIg) from plasma of donors immunized with the BNT162b2 (Pfizer-BioNTech) anti-COVID-19 vaccine (VP-IVIg) and compared their in vitro efficacy and safety with those of a similar formulation produced from plasma of COVID-19 convalescent donors (CP-IVIg). Both formulations showed immunological, physicochemical, biochemical, and microbiological characteristics that meet the specifications of IVIg formulations. Moreover, the concentration of anti-RBD and ACE2-RBD neutralizing antibodies was higher in VP-IVIg than in CP-IVIg. In concordance, plaque reduction neutralization tests showed inhibitory concentrations of 0.03–0.09 g/L in VP-IVIg and of 0.06–0.13 in CP-IVIg. Thus, VP-IVIg has in vitro efficacy and safety profiles that justify their evaluation as therapeutic alternative for clinical cases of COVID-19. Precipitation with caprylic acid could be a simple, feasible, and affordable alternative to produce formulations of anti-SARS-CoV-2 IVIg to be used therapeutically or prophylactically to confront the COVID-19 pandemic in middle and low-income countries. Despite vaccines are the main strategy to control the ongoing global COVID-19 pandemic, their effectiveness could not be enough for individuals with immunosuppression. In these cases, as well as in patients with moderate/severe COVID-19, passive immunization with anti-SARS-CoV-2 immunoglobulins could be a therapeutic alternative. We used caprylic acid precipitation to prepare a pilot-scale batch of anti-SARS-CoV-2 intravenous immunoglobulins (IVIg) from plasma of donors immunized with the BNT162b2 (Pfizer-BioNTech) anti-COVID-19 vaccine (VP-IVIg) and compared their efficacy and safety with those of a similar formulation produced from plasma of COVID-19 convalescent donors (CP-IVIg). Both formulations showed immunological, physicochemical, biochemical, and microbiological characteristics that meet the specifications of IVIg formulations. Moreover, the concentration of anti-RBD and ACE2-RBD neutralizing antibodies was higher in VP-IVIg than in CP-IVIg. In concordance, plaque reduction neutralization tests showed inhibitory concentrations of 0.03-0.09 g/L in VP-IVIg and of 0.06-0.13 in CP-IVIg. Thus, VP-IVIg has efficacy and safety profiles that justify their evaluation as therapeutic alternative for clinical cases of COVID-19. Precipitation with caprylic acid could be a simple, feasible, and affordable alternative to produce formulations of anti-SARS-CoV-2 IVIg to be used therapeutically or prophylactically to confront the COVID-19 pandemic in middle and low-income countries. Despite vaccines are the main strategy to control the ongoing global COVID-19 pandemic, their effectiveness could not be enough for individuals with immunosuppression. In these cases, as well as in patients with moderate/severe COVID-19, passive immunization with anti-SARS-CoV-2 immunoglobulins could be a therapeutic alternative. We used caprylic acid precipitation to prepare a pilot-scale batch of anti-SARS-CoV-2 intravenous immunoglobulins (IVIg) from plasma of donors immunized with the BNT162b2 (Pfizer-BioNTech) anti-COVID-19 vaccine (VP-IVIg) and compared their in vitro efficacy and safety with those of a similar formulation produced from plasma of COVID-19 convalescent donors (CP-IVIg). Both formulations showed immunological, physicochemical, biochemical, and microbiological characteristics that meet the specifications of IVIg formulations. Moreover, the concentration of anti-RBD and ACE2-RBD neutralizing antibodies was higher in VP-IVIg than in CP-IVIg. In concordance, plaque reduction neutralization tests showed inhibitory concentrations of 0.03-0.09 g/L in VP-IVIg and of 0.06-0.13 in CP-IVIg. Thus, VP-IVIg has in vitro efficacy and safety profiles that justify their evaluation as therapeutic alternative for clinical cases of COVID-19. Precipitation with caprylic acid could be a simple, feasible, and affordable alternative to produce formulations of anti-SARS-CoV-2 IVIg to be used therapeutically or prophylactically to confront the COVID-19 pandemic in middle and low-income countries.Despite vaccines are the main strategy to control the ongoing global COVID-19 pandemic, their effectiveness could not be enough for individuals with immunosuppression. In these cases, as well as in patients with moderate/severe COVID-19, passive immunization with anti-SARS-CoV-2 immunoglobulins could be a therapeutic alternative. We used caprylic acid precipitation to prepare a pilot-scale batch of anti-SARS-CoV-2 intravenous immunoglobulins (IVIg) from plasma of donors immunized with the BNT162b2 (Pfizer-BioNTech) anti-COVID-19 vaccine (VP-IVIg) and compared their in vitro efficacy and safety with those of a similar formulation produced from plasma of COVID-19 convalescent donors (CP-IVIg). Both formulations showed immunological, physicochemical, biochemical, and microbiological characteristics that meet the specifications of IVIg formulations. Moreover, the concentration of anti-RBD and ACE2-RBD neutralizing antibodies was higher in VP-IVIg than in CP-IVIg. In concordance, plaque reduction neutralization tests showed inhibitory concentrations of 0.03-0.09 g/L in VP-IVIg and of 0.06-0.13 in CP-IVIg. Thus, VP-IVIg has in vitro efficacy and safety profiles that justify their evaluation as therapeutic alternative for clinical cases of COVID-19. Precipitation with caprylic acid could be a simple, feasible, and affordable alternative to produce formulations of anti-SARS-CoV-2 IVIg to be used therapeutically or prophylactically to confront the COVID-19 pandemic in middle and low-income countries. |
| Author | Segura, Álvaro Calvo, Gerardo Herrera, María Moreira-Soto, Andrés Solano, Daniela Alfaro, Jonathan Chaves-Araya, Stephanie Alape-Girón, Alberto Rojas-Jiménez, Gabriel Drexler, Jean Felix Díaz, Cecilia León, Guillermo Vargas, Mariángela Villalta, Mauren Bolaños, Kimberly Gómez, Aarón Vargas, Marco Sánchez, Andrés Sánchez, Laura Cordero, Daniel Molina, Sebastián Durán, Gina Hernández, Andrés Solano, Gabriela Cerdas, Maykel Sánchez, Adriana |
| AuthorAffiliation | 6 Centro de Investigación en Enfermedades Tropicales (CIET), Facultad de Microbiología, Universidad de Costa Rica , San Jose , Costa Rica 3 Laboratorio Clínico y Banco de Sangre de la Universidad de Costa Rica, Oficina de Bienestar y Salud, Universidad de Costa Rica , San José , Costa Rica 5 Institute of Virology, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health , Berlin , Germany 7 German Centre for Infection Research (DZIF), Associated Partner Charité-Universitätsmedizin Berlin , Berlin , Germany 1 Sección de Virología Médica, Departamento de Microbiología e Inmunología, Facultad de Microbiología, Universidad de Costa Rica , San José , Costa Rica 2 Instituto Clodomiro Picado, Factulad de Microbiología, Universidad de Costa Rica , San José , Costa Rica 4 Banco Nacional de Sangre, Gerencia Médica, Caja Costarricense del Seguro Social , San José , Costa Rica 8 Departamento de Bioquímica, Escuela de |
| AuthorAffiliation_xml | – name: 8 Departamento de Bioquímica, Escuela de Medicina, Universidad de Costa Rica , San José , Costa Rica – name: 7 German Centre for Infection Research (DZIF), Associated Partner Charité-Universitätsmedizin Berlin , Berlin , Germany – name: 2 Instituto Clodomiro Picado, Factulad de Microbiología, Universidad de Costa Rica , San José , Costa Rica – name: 6 Centro de Investigación en Enfermedades Tropicales (CIET), Facultad de Microbiología, Universidad de Costa Rica , San Jose , Costa Rica – name: 4 Banco Nacional de Sangre, Gerencia Médica, Caja Costarricense del Seguro Social , San José , Costa Rica – name: 3 Laboratorio Clínico y Banco de Sangre de la Universidad de Costa Rica, Oficina de Bienestar y Salud, Universidad de Costa Rica , San José , Costa Rica – name: 1 Sección de Virología Médica, Departamento de Microbiología e Inmunología, Facultad de Microbiología, Universidad de Costa Rica , San José , Costa Rica – name: 5 Institute of Virology, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health , Berlin , Germany |
| Author_xml | – sequence: 1 givenname: Gabriel surname: Rojas-Jiménez fullname: Rojas-Jiménez, Gabriel – sequence: 2 givenname: Daniela surname: Solano fullname: Solano, Daniela – sequence: 3 givenname: Álvaro surname: Segura fullname: Segura, Álvaro – sequence: 4 givenname: Andrés surname: Sánchez fullname: Sánchez, Andrés – sequence: 5 givenname: Stephanie surname: Chaves-Araya fullname: Chaves-Araya, Stephanie – sequence: 6 givenname: María surname: Herrera fullname: Herrera, María – sequence: 7 givenname: Mariángela surname: Vargas fullname: Vargas, Mariángela – sequence: 8 givenname: Maykel surname: Cerdas fullname: Cerdas, Maykel – sequence: 9 givenname: Gerardo surname: Calvo fullname: Calvo, Gerardo – sequence: 10 givenname: Jonathan surname: Alfaro fullname: Alfaro, Jonathan – sequence: 11 givenname: Sebastián surname: Molina fullname: Molina, Sebastián – sequence: 12 givenname: Kimberly surname: Bolaños fullname: Bolaños, Kimberly – sequence: 13 givenname: Andrés surname: Moreira-Soto fullname: Moreira-Soto, Andrés – sequence: 14 givenname: Mauren surname: Villalta fullname: Villalta, Mauren – sequence: 15 givenname: Adriana surname: Sánchez fullname: Sánchez, Adriana – sequence: 16 givenname: Daniel surname: Cordero fullname: Cordero, Daniel – sequence: 17 givenname: Gina surname: Durán fullname: Durán, Gina – sequence: 18 givenname: Gabriela surname: Solano fullname: Solano, Gabriela – sequence: 19 givenname: Aarón surname: Gómez fullname: Gómez, Aarón – sequence: 20 givenname: Andrés surname: Hernández fullname: Hernández, Andrés – sequence: 21 givenname: Laura surname: Sánchez fullname: Sánchez, Laura – sequence: 22 givenname: Marco surname: Vargas fullname: Vargas, Marco – sequence: 23 givenname: Jean Felix surname: Drexler fullname: Drexler, Jean Felix – sequence: 24 givenname: Alberto surname: Alape-Girón fullname: Alape-Girón, Alberto – sequence: 25 givenname: Cecilia surname: Díaz fullname: Díaz, Cecilia – sequence: 26 givenname: Guillermo surname: León fullname: León, Guillermo |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/35047966$$D View this record in MEDLINE/PubMed |
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| Cites_doi | 10.3233/HAB-200441 10.1080/1744666X.2021.1894927 10.3389/fimmu.2021.708523 10.1038/s41541-021-00292-w 10.1002/14651858.CD013600.pub3 10.1016/0003-9861(69)90285-9 10.3389/fmed.2021.735853 10.1056/NEJMc2103916 10.1002/eji.202048970 10.1128/mBio.03372-20 10.1177/17534666211028077 10.1016/0003-2697(65)90085-0 10.1111/trf.12280 10.1016/j.intimp.2021.108095 10.1111/trf.16378 10.3390/cells10040821 10.1371/journal.pntd.0003501 10.1016/j.cell.2021.06.021 10.1016/j.coi.2021.03.009 10.3389/fcimb.2020.587269 10.1016/j.toxicon.2013.09.010 10.3389/fcimb.2021.655896 10.1101/2021.03.10.21253260 10.1016/j.eclinm.2021.100926 10.1016/j.cell.2020.02.058 10.1021/acscentsci.1c00120 10.1038/s41598-021-89242-z 10.2217/imt-2020-0263 10.1038/s41467-020-19943-y 10.1016/j.intimp.2020.107220 10.1038/s41401-020-0485-4 10.1016/j.toxicon.2013.03.013 |
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| Copyright | Copyright © 2022 Rojas-Jiménez, Solano, Segura, Sánchez, Chaves-Araya, Herrera, Vargas, Cerdas, Calvo, Alfaro, Molina, Bolaños, Moreira-Soto, Villalta, Sánchez, Cordero, Durán, Solano, Gómez, Hernández, Sánchez, Vargas, Drexler, Alape-Girón, Díaz and León. Copyright © 2022 Rojas-Jiménez, Solano, Segura, Sánchez, Chaves-Araya, Herrera, Vargas, Cerdas, Calvo, Alfaro, Molina, Bolaños, Moreira-Soto, Villalta, Sánchez, Cordero, Durán, Solano, Gómez, Hernández, Sánchez, Vargas, Drexler, Alape-Girón, Díaz and León. 2022 Rojas-Jiménez, Solano, Segura, Sánchez, Chaves-Araya, Herrera, Vargas, Cerdas, Calvo, Alfaro, Molina, Bolaños, Moreira-Soto, Villalta, Sánchez, Cordero, Durán, Solano, Gómez, Hernández, Sánchez, Vargas, Drexler, Alape-Girón, Díaz and León |
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| Keywords | COVID-19 BNT162b2 vaccine SARS-CoV-2 hyperimmune polyclonal antibodies IVIg hyperimmune plasma passive immunotherapy convalescent plasma |
| Language | English |
| License | Copyright © 2022 Rojas-Jiménez, Solano, Segura, Sánchez, Chaves-Araya, Herrera, Vargas, Cerdas, Calvo, Alfaro, Molina, Bolaños, Moreira-Soto, Villalta, Sánchez, Cordero, Durán, Solano, Gómez, Hernández, Sánchez, Vargas, Drexler, Alape-Girón, Díaz and León. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. |
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| Notes | ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 Edited by: Laura Fregonese, European Medicines Agency, Netherlands This article was submitted to Regulatory Affairs, a section of the journal Frontiers in Medical Technology Reviewed by: Thierry Burnouf, Taipei Medical University, Taiwan; Mike Joyner, Mayo Clinic, United States |
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| Title | In vitro Characterization of Anti-SARS-CoV-2 Intravenous Immunoglobulins (IVIg) Produced From Plasma of Donors Immunized With the BNT162b2 Vaccine and Its Comparison With a Similar Formulation Produced From Plasma of COVID-19 Convalescent Donors |
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