Opportunities in formulation development of antibody-based therapeutics

Abstract Drug product formulation transforms active pharmaceutical ingredients into drug products, ensuring stability, manufacturability, efficacy, and patient safety. Driven by biotech advancements and patient needs, new antibody-based therapies and combinations are expanding, significantly evolving the formulation landscape. This editorial provides an overview of formulations for antibody-based therapeutics and highlights a few hot topics and emerging trends, including high concentration formulations, fixed-dose combinations, novel excipients and delivery technologies, and AI integration. As the field progresses, innovative technologies and sustainable practices will be important in addressing the increasing demand for antibody-based therapies. Statement of Significance This editorial provides the current landscape of formulations for antibody-based therapeutics and highlights recent hot topics and emerging trends in formulation research. The insights presented are intended to inspire continued research in driving the efforts to develop safe, robust, and patient-centric antibody-based therapeutics.