Workflow For Antibody Aggregate And Fragment Analysis

The presence of aggregates or fragments in antibody formulations is considered a paramount issue, since they can cause effects such as decreased or increased activity, increased cytotoxicity and immunogenicity, and decreased solubility of the drug. More specifically, side effects like headache, shivers, anaphylactic reactions, or renal failure as well as the development of an immune response by patients have been observed. In such a situation, the effectiveness of a drug is strongly reduced. Therefore, it is essential to characterize mAb aggregate and fragment formation during drug formulation and to establish a suitable quality control process for these therapeutics.

Learn about a complete SEC-UV workflow that has been developed to enable quantitative analysis of antibody fragments and aggregates. In detail, it includes:

• Procedure for heat stressing of antibodies
• System suitability test utilizing a gel filtration standard
• SEC-UV method for sample separation and analysis

Herein, forced temperature stress studies were conducted on a monoclonal antibody, and resulting aggregates, fragments, and monomers were separated and quantified by utilizing SEC-UV analysis.