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Preserved SARS-CoV-2 neutralizing IgG activity of in-house manufactured COVID-19 convalescent plasma
Affiliation:1. Disease Prevention and Control Center, National Center for Global Health and Medicine, 1–21-1 Toyama, Shinjuku-ku, Tokyo, Japan;2. Department of Hematology, National Center for Global Health and Medicine, 1–21-1 Toyama, Shinjuku-ku, Tokyo, Japan;3. Center for Clinical Sciences, National Center for Global Health and Medicine, 1–21-1 Toyama, Shinjuku-ku, Tokyo, Japan;4. Department of Clinical Laboratory, National Center for Global Health and Medicine, 1–21-1 Toyama, Shinjuku-ku, Tokyo, Japan;5. Department of Refractory Viral Infections, National Center for Global Health and Medicine Research Institute, 1–21-1 Toyama, Shinjuku-ku, Tokyo, Japan;6. Department of Infection Control, Graduate School of Medicine, Osaka University, 2–15 Yamadagaoka, Suita City, Osaka, Japan;7. Division of Antiviral Therapy, Joint Research Center for Human Retrovirus Infection, Kagoshima University, 8–35-1 Sakuragaoka, Kagoshima City, Kagoshima, Japan
Abstract:PurposeIn the current study, we aimed to evaluate the neutralizing IgG activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) as well as the coagulation factors of convalescent plasmas which we manufactured in-house without a fast-freezing technique.MethodsWe collected plasmas from eligible participants who had confirmed certain titers of neutralizing antibodies. The plasmas were frozen and stored in the ordinary biofreezer without a fast-freezing function. The purified-IgG neutralizing activity of 20 samples from 19 participants and the coagulation factors of 49 samples from 40 participants were evaluated before and after freezing.ResultsPurified-IgG maintained its neutralizing activities, with the median 50 % inhibitory concentration (IC50) of 10.11 mg/ml (IQR 6.53–18.19) before freezing and 8.90 m g/ml (IQR 6.92–28.27) after thawing (p = 0.956). On the contrary, fibrinogen and factor Ⅷ decreased significantly after freezing and thawing in our environment. No significant temperature deviation was observed during the storage period.ConclusionNeutralizing IgG activity, which largely contributes to the antiviral activity of convalescent plasma, did not change through our in-house manufacturing, without fastfreezing and storage conditions for more than 200 days. Ordinary freezers without the fast-freezing function are suitable enough to manufacture and store convalescent plasmas. Hospitals or facilities without specified resources could easily collect and store convalescent plasmas in case of upcoming emerging or re-emerging infectious diseases on-demand with appropriate neutralizing antibody levels measurements.
Keywords:Convalescent plasma therapy  COVID-19  SARS-CoV-2  Neutralizing antibody  Coagulation factor  Fast-freezing
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