Aggregation of Recombinant Monoclonal Antibodies and Its Role in Potential Immunogenicity

Abstract

All developed and proposed analytical methods and immunological in vitro DC and PBMC assays, could be used as platform for complementary analytical characterization and determination of potential for immunogenicity for all biopharmaceutical products which contain monoclonal antibodies as active pharmaceutical ingredients.

Intact and subunit-specific analysis of bispecific antibodies by sheathless CE-MS

“…1A) [6,7]. Still, side products such as free chains, incomplete antibodies or aggregates are commonly observed during production which can induce unwanted immunological responses [8]. This so-called macroheterogeneity should be carefully monitored to ensure patient safety.…”