Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Editorial
. 2025 Aug 22;8(3):259-261.
doi: 10.1093/abt/tbaf016. eCollection 2025 Jul.

Opportunities in formulation development of antibody-based therapeutics

Affiliations
Editorial

Opportunities in formulation development of antibody-based therapeutics

Qingyan Hu et al. Antib Ther. .

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.

Keywords: antibody formulation; antibody-based theraputics; emerging formulation trend; fixed-dose combination; high concentration formulation; novel excipient.

PubMed Disclaimer

Conflict of interest statement

QH is employed by Regeneron Pharmaceuticals, Inc. YL is employed by Eli Lilly and Company. The authors declare no conflicts of interest with respect to the research, authorship, and/or publication of this editorial.

References

    1. Cheng Y, Duong HTT, Hu Q. et al. Practical advice in the development of a lyophilized protein drug product. Antibody Ther 2025;8:13–25. 10.1093/abt/tbae030. - DOI - PMC - PubMed
    1. Zhang X, Zhou N, Yang C. et al. Multiple approaches to reduce reconstitution time of lyophilized drug products with high protein concentration. Antibody Ther 2024;7:67–76. 10.1093/abt/tbad031. - DOI - PMC - PubMed
    1. Ren S. Effects of arginine in therapeutic protein formulations: a decade review and perspectives. Antibody Ther 2023;6:265–76. 10.1093/abt/tbad022. - DOI - PMC - PubMed
    1. Xin L, Lan L, Mellal M. et al. Leveraging high-throughput analytics and automation to rapidly develop high-concentration mAb formulations: integrated excipient compatibility and viscosity screening. Antibody Ther 2024;7:335–50. 10.1093/abt/tbae028. - DOI - PMC - PubMed
    1. Wen L, Zhang Y, Sun C. et al. Fundamental properties and principal areas of focus in antibody–drug conjugates formulation development. Antibody Ther 2025;8:99–110. 10.1093/abt/tbaf005. - DOI - PMC - PubMed

Publication types

LinkOut - more resources