C. Russell Middaugh

TL;DR: The purpose of this commentary is to provide brief summaries on the factors affecting protein aggregation and the key aspects of protein aggregation that are associated with immunogenicity, and emphasize the current scientific gaps in understanding and analytical limitations for quantitation of species of large protein aggregates that are referred to as subvisible particles.

TL;DR: Clinical trial results for various vaccine adjuvants and delivery vehicles being developed that are approximately nanoscale (<1000 nm) in size are discussed.

TL;DR: The use of various synthetic lipids and polymers to deliver DNA for gene therapy applications and various formulation variables that have been explored to overcome these delivery barriers to nonviral gene delivery are outlined.

TL;DR: Key mechanisms of protein-excipient interactions such as electrostatic and cation-pi interactions, preferential hydration, dispersive forces, and hydrogen bonding are presented in the context of different physical states of the formulation.

TL;DR: Key concepts in understanding the causes and mechanisms of vaccine instability are covered including the complex and delicate nature of antigen structures, as well as formulation approaches for stabilization within the vaccine cold chain.