Current status and prospect for future advancements of long-acting antibody formulations.

Abstract

Introduction: Biologics, especially monoclonal antibodies (mAbs), have become a major class of therapeutics in recent years addressing the needs of millions of patients and becoming one of the best-selling treatments in the pharmaceutical market. A wide range of multifaceted chronic diseases have benefitted from antibody therapeutics. Long-term treatment for chronic diseases with mAb therapies can mean a lifetime of frequent injections. Technologies that can minimize the total number of injections present meaningful value to patients and the companies that develop them.

Areas covered: This review summarizes the challenges encountered during the development of long-acting versions of mAbs. The focus will be on questions addressed during drug product development, delivery device selection, business implications, and understanding the market potential of long-acting presentations.

Expert opinion: Long-acting drug delivery systems have reached the market for small molecules and peptides. However, these drug delivery systems, and their development lessons, cannot be extrapolated directly to antibodies. We must develop new delivery technologies suitable for biologics, identify critical attributes to capture dynamic changes in proteins during the encapsulation process, and develop analytical processes to evaluate long-term stability.