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30 Pharmaceutical Technology ® Trends in Formulation 2022 eBook PharmTech.com MR.ILKIN - STOCK.ADOBE.COM T here is a growing demand for biologics spurred by clinical success, favorable safe- ty data, and the ability of biologics to target the underlying cause of disease. Progress in proteins, peptides, nucleic acids, vaccines, and mono- clonal antibodies (mAbs) has allowed biologics to ad- vance quickly, especially in recent years. According to an article in Molecules, 25% of new chemical en- tities approved by FDA between 2015 and 2019 were biologics (1). Perhaps the most striking recent exam- ple 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, thermo- stability, and drug delivery. Biologics originate from living organisms, have large molecular weights, and generally cannot be chemically synthesized. This means they are vulner- able to the environment and require extreme care to formulate, manufacture, and store (2). As biologics are large molecules with primary, secondary, tertiary, and quaternar y structures, they are also sensitive and expensive to produce (3). While biologics are con- ventionally 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 con- sider shelf stability as well as which excipients and formulation conditions will enable a longer shelf life. Additionally, the chemical and physical properties of Improved Formulations to Enable Stable Delivery of Biologics Robert O. Williams III, PhD is the technology inventor/ special advisor for TFF Pharmaceuticals. How dry powder techniques can overcome limitations in biologics development and delivery to broaden routes of administration and global accessibility.