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.

KEYWORDS:

• Biologic
• long-acting formulations
• drug delivery technologies
• subcutaneous drug delivery
• patient preference

Article highlights

• Biologics such as mAbs are a key therapeutic modality in today’s pharmaceutical world.

• Long-acting presentations for mAbs can improve patient comfort and adherence through less frequent injections.

• Key challenges in developing long-acting presentations for mAbs have been discussed with directional guidance to potential solutions.

Acknowledgments

The authors would like to thank Evo Pazarentzos and Megan Heft for their contributions to the authors’ thought process and participation in past panel discussions on this topic. The authors also thank Patrick Rehfuss for his critical review and insightful comments.

Declaration of interest

P Tyagi, S P Davis, G Harper, and P McGeehan are all employees of and shareholders in AstraZeneca. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper was not funded.