Journal of Pharmaceutical Analysis and Drug Research ISSN: 3108-0839 (Online)

Authors: Dr. Ananya Mehta, Dr. Rohan Choudhary

Abstract: The evolution of novel therapeutic modalities, including monoclonal antibodies, antibody-drug conjugates, oligonucleotides, peptides, cell-based therapies, and gene therapy products, has reshaped the biopharmaceutical landscape. With these advancements, bioanalytical method development has become increasingly critical for understanding pharmacokinetics, pharmacodynamics, immunogenicity, and safety. Unlike traditional small molecules, these complex modalities demand tailored analytical approaches, advanced instrumentation, and innovative strategies to ensure sensitivity, selectivity, reproducibility, and regulatory compliance. This paper discusses the importance of bioanalytical method development for novel modalities, highlights key techniques, outlines challenges, and explores the scope of future innovations in the field.

Keywords: Bioanalytical methods, novel modalities, monoclonal antibodies, oligonucleotides, peptides, gene therapy, immunogenicity, pharmacokinetics, regulatory sciences, analytical validation.