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.