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.
Highlights
SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2) is an enveloped, positive sense RNA virus, composed of four structural proteins: envelope (E), membrane (M), nucleocapsid (N), and the homotrimeric spike (S) protein
Vaccinated plasma was obtained by Banco de Sangre de la Universidad de Costa Rica from the blood of 101 donors who had been immunized with the BNT162b2 anti-COVID-19 vaccine (Pfizer-BioNTech), within the first 12 weeks after vaccination
Convalescent plasma was obtained by C.C.S.S. through of the Banco Nacional de Sangre, from the blood of 158 donors who were diagnosed by direct detection of SARS-CoV-2 RNA in swabs of the upper respiratory tract, developed mild or moderate symptomatology of COVID-19, and made a full recovery
Summary
SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2) is an enveloped, positive sense RNA virus, composed of four structural proteins: envelope (E), membrane (M), nucleocapsid (N), and the homotrimeric spike (S) protein. Given the absence of effective treatments for treating the disease, many efforts to reduce the effects of COVID-19 have focused on the development of vaccines and immunoglobulin formulations, for active and passive immunization, respectively [4, 5] In both cases, anti-RBD antibodies have been identified as promising candidates to increase resistance against infection [1, 6, 7]. Despite the potential of anti-COVID-19 vaccines as prophylactic drugs, their effectiveness could be diminished in individuals with lymphopenia, primary/secondary antibody deficiencies, or suffering from moderate/severe COVID-19 In these cases, passive immunization with preparations of anti-SARS-CoV-2 antibodies might be a therapeutic option [8]. We evaluated the performance of the caprylic acid precipitation method at pilotscale as a plasma fractionation downstream strategy to produce both formulations
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
