Journey Of A Therapeutic Antibody: From Preclinical To Clinical Proof Of Concept Development

By Amanda Woodrooffe, PhD and Rachel Owen, PhD, Precision for Medicine

Therapeutic antibodies continue to dominate the biopharmaceutical landscape, propelled by innovations in antibody engineering and expanding applications across oncology, immunology, and infectious disease. This eBook traces the early development journey of a therapeutic antibody, emphasizing the critical role of robust biomarker strategies and analytical assays. it serves as a valuable resource, offering detailed guidance to help researchers and clinicians bring innovative treatments to patients. Case studies, including a validated assay for screening anti-TNFα biosimilars, illustrate real-world challenges and solutions in assay development. The importance of evaluating disposition and safety, pharmacokinetics, immunogenicity, and off-target binding through GLP-compliant tissue cross-reactivity studies is underscored. Ultimately, successful antibody development hinges on deep biological insight, strategic biomarker integration, and strong technical partnerships—laying the foundation for safer, more effective therapies and successful regulatory outcomes.