Frontiers in Medical Technology (Jan 2022)

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

  • Gabriel Rojas-Jiménez,
  • Daniela Solano,
  • Álvaro Segura,
  • Andrés Sánchez,
  • Stephanie Chaves-Araya,
  • María Herrera,
  • Mariángela Vargas,
  • Maykel Cerdas,
  • Gerardo Calvo,
  • Jonathan Alfaro,
  • Sebastián Molina,
  • Kimberly Bolaños,
  • Andrés Moreira-Soto,
  • Andrés Moreira-Soto,
  • Mauren Villalta,
  • Adriana Sánchez,
  • Daniel Cordero,
  • Gina Durán,
  • Gabriela Solano,
  • Aarón Gómez,
  • Andrés Hernández,
  • Laura Sánchez,
  • Marco Vargas,
  • Jean Felix Drexler,
  • Jean Felix Drexler,
  • Alberto Alape-Girón,
  • Alberto Alape-Girón,
  • Cecilia Díaz,
  • Cecilia Díaz,
  • Guillermo León

DOI
https://doi.org/10.3389/fmedt.2021.772275
Journal volume & issue
Vol. 3

Abstract

Read online

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.

Keywords