Improved formulations to enable stable delivery of biologics


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

There is a growing demand for biologics driven by clinical success, favorable safety data, and the ability of biologics to target the underlying cause of disease. Advances in proteins, peptides, nucleic acids, vaccines and monoclonal antibodies (mAbs) have allowed biologics to advance rapidly, especially in recent years. According to an article by Molecules, 25% of new chemical entities approved by the FDA between 2015 and 2019 were biologics (1). Perhaps the most striking recent example of demand for biologics is the rapid scale-up and application of messenger RNA (mRNA) vaccines to treat COVID-19. Although progress has been rapid, challenges have created barriers to global adoption due to complications with drug formulation, thermostability, and delivery.

Biologics come from living organisms, have high molecular weights, and generally cannot be synthesized chemically. This means that they are vulnerable to the environment and require extreme care to be formulated, manufactured, and stored (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 traditionally administered intravenously in liquid form, liquid formulations present chemical and physical stability issues. Conversely, biologics formulated as a dry powder are more stable and less prone to degradation, but drug manufacturers must consider shelf stability as well as excipients and formulation conditions that will allow longer shelf life. Additionally, the chemical and physical properties of the final product must be considered when formulating to accommodate the route of administration.

This article explores technological innovations that could overcome the challenges of biologics formulation and delivery, particularly for respiratory diseases where inhaled drug delivery offers significant benefit, to address the need for the scale of biologics to benefit a wide range of patients.

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

About the Author

Robert O. Williams III, PhD, is Division Chief and Professor of Molecular Pharmacy 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 of the scientific journal PharmSciTech of the American Association of Pharmaceutical Scientists (AAPS); and technology inventor/special advisor, TFF Pharmaceuticals.

Item details

Pharmaceutical technology
eBook: Formulation Trends 2022
October 2022
Pages: 30 to 35


When referring to this article, please cite it as RO Williams III, “Improved Formulations to Enable Stable Delivery of Biologics”, Pharmaceutical technologyeBook Trends in Formulation (2022).


Comments are closed.