Determination of titer and evaluation of quality parameter (soluble aggregates) of monoclonal antibody using Protein- A Affinity and size exclusion chromatography

Abstract

Antibodies are biologic protein components that are produced by B lymphocytes, responsible for binding and neutralizing antigens and pathogens. Antibodies tend to bind to its equivalent antigen in a highly specific manner through the Fab domain of an immunoglobulin giving antibody its recognized function. On the other hand, Fc region of the immunoglobulin binds with the surface receptors called Fc receptors. This activity activates the immune response and is responsible for providing immune mediated-effector functions. Antibodies are of two types, Polyclonal antibody and monoclonal antibody. Polyclonal antibodies are those which inherit from different cell lineages and are secreted against a specific antigen, each having the capacity to identify a specific epitope. Contrastingly, monoclonal antibodies are derived from a single cell lineage and have monovalent affinity that is they are specific to a single epitope. In India, most of the biopharmaceutical industries focus majorly on target specific biotherapeutics, amongst which monoclonal antibodies are major one as a biosimilar.