High Resolution Mass Spectrometric Analysis Of Complex Biotherapeutics

Emerging classes of biotherapeutics — such as antibody-oligonucleotide conjugates (AOCs) and other oligonucleotide-based therapies — offer significant advantages, including enhanced target specificity and minimized off-target effects. Despite these promising attributes, the inherent complexity of their molecular structures presents considerable challenges throughout development. These therapeutic agents vary widely in size, structure, and chemical composition, necessitating tailored approaches in formulation, manufacturing, and analysis. As a result, they introduce a host of novel regulatory considerations that differ from those associated with traditional small molecules or biologics.

Regulatory frameworks for these innovative modalities are still evolving, driven by a growing understanding of critical quality attributes such as impurities, degradation products, and their potential clinical implications. Continued research and collaboration between industry and regulatory bodies are essential to define comprehensive guidelines that ensure both safety and efficacy in this rapidly advancing field.