Robert O. Williams III, PhD, is the division head and professor of molecular pharmaceutics and drug delivery at The University of Texas at Austin, College of Pharmacy; the Johnson & Johnson centennial chair in pharmacy at the University of Texas at Austin, College of Pharmacy; editor-in-chief of the AAPS PharmSciTech scientific journal; and the technology inventor/special advisor for TFF Pharmaceuticals.

Robert O. Williams III

There is a growing demand for biologics spurred by clinical success, favorable safety data, and the ability of biologics to target the underlying cause of disease. Progress in proteins, peptides, nucleic acids, vaccines, and monoclonal antibodies (mAbs) has allowed biologics to advance quickly, especially in recent years. According to an article in 

, 25% of new chemical entities approved by FDA between 2015 and 2019 were biologics (1). Perhaps the most striking recent example of the demand for biologics is the rapid scale-up and application of messenger RNA (mRNA) vaccines to treat COVID-19. Though progress has been swift, challenges have created barriers to global adoption due to complications related to formulation, thermostability, and drug delivery. 

Improved Formulations to Enable Stable Delivery of Biologics

Pharmaceutical Technology's Trends in Formulation 2022 eBook

Biologics originate from living organisms, have large molecular weights, and generally cannot be chemically synthesized. This means they are vulnerable to the environment and require extreme care to formulate, manufacture, and store (2). As biologics are large molecules with primary, secondary, tertiary, and quaternary structures, they are also sensitive and expensive to produce (3). While biologics are conventionally delivered intravenously in liquid form, liquid formulations exhibit chemical and physical stability problems. Conversely, biologics formulated as a dry powder are more stable and are less prone to degradation, but drug manufacturers must consider shelf stability as well as which excipients and formulation conditions will enable a longer shelf life. Additionally, the chemical and physical properties of the final product must be considered during formulation to fit the route of administration.

This article explores technological innovations that could overcome challenges in formulation and the delivery of biologics—especially for respiratory diseases where inhaled drug delivery offers a significant advantage—to address the need for scale-up of biologics to benefit a broad range of patients.

Read the full article in the Trends in Formulation 2022 eBook.

Robert O. Williams III, PhD, is the division head and professor of molecular pharmaceutics and drug delivery at The University of Texas at Austin, College of Pharmacy; the Johnson & Johnson centennial chair in pharmacy at the University of Texas at Austin, College of Pharmacy; editor-in-chief of the American Association of Pharmaceutical Scientists (AAPS) PharmSciTech scientific journal; and the technology inventor/special advisor, TFF Pharmaceuticals.


eBook: Trends in Formulation 2022
October 2022
Pages: 30–35

When referring to this article, please cite it as R. O. Williams III, "Improved Formulations to Enable Stable Delivery of Biologics," 

Articles

How dry powder techniques can overcome limitations in biologics development and delivery to broaden routes of administration and global accessibility.