Uses and Challenges of Antiviral Polyclonal and Monoclonal Antibody Therapies

Viral diseases represent a major public health concerns and ever-present risks for developing into future pandemics. Antiviral antibody therapeutics, either alone or in combination with other therapies, emerged as valuable preventative and treatment options, including during global emergencies. Here...

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Main Authors: Evi B. Struble, Jonathan M. O. Rawson, Tzanko Stantchev, Dorothy Scott, Marjorie A. Shapiro
Format: Article
Language:English
Published: MDPI AG 2023-05-01
Series:Pharmaceutics
Subjects:
Online Access:https://www.mdpi.com/1999-4923/15/5/1538
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author Evi B. Struble
Jonathan M. O. Rawson
Tzanko Stantchev
Dorothy Scott
Marjorie A. Shapiro
author_facet Evi B. Struble
Jonathan M. O. Rawson
Tzanko Stantchev
Dorothy Scott
Marjorie A. Shapiro
author_sort Evi B. Struble
collection DOAJ
description Viral diseases represent a major public health concerns and ever-present risks for developing into future pandemics. Antiviral antibody therapeutics, either alone or in combination with other therapies, emerged as valuable preventative and treatment options, including during global emergencies. Here we will discuss polyclonal and monoclonal antiviral antibody therapies, focusing on the unique biochemical and physiological properties that make them well-suited as therapeutic agents. We will describe the methods of antibody characterization and potency assessment throughout development, highlighting similarities and differences between polyclonal and monoclonal products as appropriate. In addition, we will consider the benefits and challenges of antiviral antibodies when used in combination with other antibodies or other types of antiviral therapeutics. Lastly, we will discuss novel approaches to the characterization and development of antiviral antibodies and identify areas that would benefit from additional research.
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spelling doaj.art-ac65fe98a31d4dfb937e9e7ec43bf6892023-11-18T02:53:01ZengMDPI AGPharmaceutics1999-49232023-05-01155153810.3390/pharmaceutics15051538Uses and Challenges of Antiviral Polyclonal and Monoclonal Antibody TherapiesEvi B. Struble0Jonathan M. O. Rawson1Tzanko Stantchev2Dorothy Scott3Marjorie A. Shapiro4Division of Plasma Derivatives, Office of Plasma Protein Therapeutics CMC, Office of Therapeutic Products, Center for Biologics Evaluation and Research, United States Food and Drug Administration, Silver Spring, MD 20993, USADivision of Antivirals, Office of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, MD 20993, USADivision of Biotechnology Review and Research 1, Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, MD 20993, USADivision of Plasma Derivatives, Office of Plasma Protein Therapeutics CMC, Office of Therapeutic Products, Center for Biologics Evaluation and Research, United States Food and Drug Administration, Silver Spring, MD 20993, USADivision of Biotechnology Review and Research 1, Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, MD 20993, USAViral diseases represent a major public health concerns and ever-present risks for developing into future pandemics. Antiviral antibody therapeutics, either alone or in combination with other therapies, emerged as valuable preventative and treatment options, including during global emergencies. Here we will discuss polyclonal and monoclonal antiviral antibody therapies, focusing on the unique biochemical and physiological properties that make them well-suited as therapeutic agents. We will describe the methods of antibody characterization and potency assessment throughout development, highlighting similarities and differences between polyclonal and monoclonal products as appropriate. In addition, we will consider the benefits and challenges of antiviral antibodies when used in combination with other antibodies or other types of antiviral therapeutics. Lastly, we will discuss novel approaches to the characterization and development of antiviral antibodies and identify areas that would benefit from additional research.https://www.mdpi.com/1999-4923/15/5/1538antiviral therapyantiviral antibodiesantibody combination therapyantibody potencypotency assays
spellingShingle Evi B. Struble
Jonathan M. O. Rawson
Tzanko Stantchev
Dorothy Scott
Marjorie A. Shapiro
Uses and Challenges of Antiviral Polyclonal and Monoclonal Antibody Therapies
Pharmaceutics
antiviral therapy
antiviral antibodies
antibody combination therapy
antibody potency
potency assays
title Uses and Challenges of Antiviral Polyclonal and Monoclonal Antibody Therapies
title_full Uses and Challenges of Antiviral Polyclonal and Monoclonal Antibody Therapies
title_fullStr Uses and Challenges of Antiviral Polyclonal and Monoclonal Antibody Therapies
title_full_unstemmed Uses and Challenges of Antiviral Polyclonal and Monoclonal Antibody Therapies
title_short Uses and Challenges of Antiviral Polyclonal and Monoclonal Antibody Therapies
title_sort uses and challenges of antiviral polyclonal and monoclonal antibody therapies
topic antiviral therapy
antiviral antibodies
antibody combination therapy
antibody potency
potency assays
url https://www.mdpi.com/1999-4923/15/5/1538
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