Drug intelligence / Profile preview

pepsin-treated immunoglobulin

Development stage
Preclinical
Lead developer
CSL Behring
Modality
Recombinant Proteins and Enzymes, Antibody Fragments → Engineered Antibody Formats → Antibody-Based Therapeutics
Administration
Intravenous
01

Overview

Pepsin-treated immunoglobulin refers to human or animal-derived immunoglobulins (typically IgG) that have been subjected to limited proteolysis with the enzyme pepsin. This process cleaves the Fc region of IgG, yielding F(ab')₂ fragments while removing most of the Fc portion. The resulting product retains antigen-binding capacity but has reduced ability to activate complement and bind Fc receptors. Pepsin treatment is used in manufacturing some intravenous immunoglobulin (IVIG) products both for viral inactivation and for generating antibody fragments with altered effector functions. Pepsin-treated IVIG has been investigated as adjunctive therapy in bacterial infections such as sepsis and pneumonia, but clinical studies have not shown significant benefit over antibiotics alone[5]. It is also a step in producing certain commercial IVIG preparations[3][9]. Mechanistically, these preparations provide passive immunity by supplying exogenous antibodies capable of neutralizing pathogens and modulating immune responses.

Brand names
Gamma-Venin
Other names
pepsin-treated human gamma globulinpepsin-treated immunoglobulinpepsin-digested immunoglobulin

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