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, spurred 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 enabled biologics to advance rapidly, especially in recent years. According to an article in molecules, 25% of the new chemical substances approved by the FDA between 2015 and 2019 were biologics (1). Perhaps the most striking recent example of demand for biologics is the rapid expansion and application of messenger RNA (mRNA) vaccines to treat COVID-19. Although advances have been rapid, challenges related to formulation complications, thermostability, and drug delivery have created barriers to global adoption.
Biologics are derived from living organisms, have large molecular weights, and generally cannot be chemically synthesized. This means that they are vulnerable to the environment and require extreme care in their formulation, manufacture and storage (2). Because biologics are large molecules with primary, secondary, tertiary, and quaternary structures, they are also delicate and expensive to manufacture (3). While biologics are traditionally administered intravenously in liquid form, liquid formulations present chemical and physical stability problems. Conversely, biologics formulated as dry powders are more stable and less prone to degradation, but drug manufacturers must consider storage stability as well as excipients and formulation conditions that allow for longer shelf lives. Additionally, the chemical and physical properties of the final product must be considered during formulation to suit the route of administration.
This article examines technological innovations that could overcome challenges in biologics formulation and delivery—particularly in respiratory diseases, where inhaled drug delivery offers a significant advantage—to address the need to scale biologics to benefit a broad spectrum of patients.
Read the full article in the Trends in Formulation 2022 eBook.
About the author
Robert O. Williams III, PhD, is a department head 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-in-Chief of the American Association of Pharmaceutical Scientists (AAPS) scientific journal PharmSciTech; and technology inventor/specialist consultant TFF Pharmaceuticals.
eBook: Formulation Trends 2022
When referring to this article, please cite it as RO Williams III, “Improved Formulations to Enable Stable Delivery of Biologics”, pharmaceutical technology‘s Trends in eBook Formulation (2022).