Analysis of Monoclonal Antibodies and Antibody Drug Conjugates (ADCs) / LC & LCMS/MS

Applications for LC & LCMS/MS

 
 

Development of MRM Methods for Monoclonal Antibodies Using Skyline

Monoclonal antibodies, or mAbs, have been used for over a decade in the treatment of a number of diseases but predominantly in the treatment of cancer and autoimmune diseases. Quantifying therapeutic mAbs in biological samples has been traditionally addressed by ligand binding assays (LBA’s), however, there are major limitation in terms of extended method development times, reagent procurement, and matrix effects. LC-MS/MS methods are emerging as an alternative approach to LBA’s and this paper describes the application of MRM methods to the quantitation of peptide fragments containing β-amyloid antibody (6E10) CDR’s (complementarity determining regions).

 
 
 
 
 
 
 
 
 

Analysis of mAb Aggregates by Nexera Bio UHPLC with Shim-Pack BioDiol Size Exclusion Column

Monoclonal antibodies are important biologics for the treatment od cancers. The production of mAb biosimilar is challenging, because various variations may occur in upstream and downstream processing (DSP). Protein aggregation is one of such variations – a biological phenomenon in which mAb accumulate and clump together. Aggregation is a critical quality attributes (CQA), as the aggregates not only reduce the efficacy of mAb biosimilar drug, but also can stimulate immunogenic responses, leading to various adverse events in treatment. Thus, the accurate analysis of monomer, dimer and higher aggregates of mAb is required for developing higher quality therapeutics. 

 
 
 
 
 
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