Antibody / ADC / AOC Analyses
Antibodies (mAbs, bispecifics, etc.)
Liquid chromatography–mass spectrometry (LC-MS) is a powerful analytical tool for characterizing monoclonal antibodies (mAbs), particularly when it comes to identifying and monitoring critical quality attributes (CQAs). These attributes—such as glycosylation patterns, oxidation states, deamidation events, sequence variants, and aggregation — can significantly impact the safety, efficacy, and stability of the therapeutic antibody. Rilas enables researchers to gain high-resolution analysis at multiple structural levels, including intact mass, subunit, peptide, and released glycan. By providing detailed molecular insights, Rilas helps ensure batch-to-batch consistency for in vivo experimentation, supports the building of regulatory compliance methods, and guides process optimization throughout the development and manufacturing lifecycle of antibodies.
Antibody-Drug Conjugates (ADCs)
Rilas extends it’s antibody analysis to antibody-drug conjugates (ADCs), where the complexity increases due to the addition of cytotoxic payloads. LC-MS allows precise determination of drug-to-antibody ratio (DAR), identification of conjugation sites, and assessment of heterogeneity introduced by the linker and payload. Rilas also specializes in the detection of degradation products, payload-related modifications, and changes in glycosylation or other critical quality attributes that may affect ADC potency, stability, and safety, and in the removal of these contaminants. By integrating intact mass analysis, subunit-level dissection, and peptide mapping, Rilas provides a comprehensive understanding of ADC structure and quality, essential for successful therapeutic development.
Antibody-Oligonucleotide Conjugates (AOCs)
Antibody-oligonucleotide conjugates (AOCs) are of emerging therapeutic interest, and LC-MS plays a critical role in characterizing these complex bioconjugates. AOCs combine the specificity of monoclonal antibodies with the gene-modulating potential of oligonucleotides, making precise structural and quality assessment even more essential. Rilas enables accurate determination of the oligonucleotideto-antibody ratio (OAR), identification of conjugation sites, and evaluation of molecular heterogeneity introduced during conjugation. It can also detect modifications or degradation of the oligonucleotide, linker stability, and potential impacts on the antibody’s critical quality attributes such as glycosylation or oxidation. Through intact mass analysis, subunit analysis, and targeted peptide or oligonucleotide analysis, Rilas provides a detailed view of AOC composition and integrity—ensuring product consistency, functionality, and safety throughout development and manufacturing.
Instrumentation:
Agilent 6545XT AdvanceBio LC/Q-TOF
Agilent 1290 Infinity II HPLC/MS
Agilent 1260 HPLC/UV/ELSD