Excipient Innovation Through Precompetitive Research

Published

December 20, 2021

Author(s)

Bruce Yu, Marc Taraban, Katharine Briggs, Robert Brinson, John Marino

Abstract

The mRNA COVID-19 vaccines developed by Pfizer/BioNTech and Moderna represent a triumph of vaccine development. The core mRNA component of these vaccines is now almost a household name. Unbeknownst to most people, however, is that each of the two mRNA COVID vaccines contains two novel excipients; a cationic lipid and a PEGylated cationic lipid (1, 2), which form the lipid nanoparticle that protects and delivers the mRNA to the patient. Were it not for these two novel excipients, the delivery of mRNA vaccines would be problematic, or not possible at all. This situation is typical for excipients, essential ingredients of pharmaceutical products that work behind the scenes and go unnoticed by the general public. Compared to the development of novel drugs, the development of novel excipients has received much less attention and investment. In this Perspective, we argue that excipients should be treated as infrastructure of the pharmaceutical sector and given their criticality in therapeutic success, there is a need for focused research aimed specifically at novel excipient discovery and development.

Citation

Pharmaceutical Research

Volume

38

Pub Type

Journals

Download Paper

https://doi.org/10.1007/s11095-021-03157-y

Local Download

Keywords

excipients, formulation, biologics, vaccines, precompetitive research

Citation

Yu, B. , Taraban, M. , Briggs, K. , Brinson, R. and Marino, J. (2021), Excipient Innovation Through Precompetitive Research, Pharmaceutical Research, [online], https://doi.org/10.1007/s11095-021-03157-y, https://tsapps.nist.gov/publication/get_pdf.cfm?pub_id=933677 (Accessed October 12, 2025)