Abstract: The present disclosure provides stable lyophilized pharmaceutical compositions comprising recombinant adeno-associated virus (rAAV) particles. In certain embodiments, the compositions contain, in addition to the rAAV particles, a buffer, one or more salts, a surfactant, a bulking agent, and a sugar. The pharmaceutical compositions of the present disclosure exhibit a substantial degree of rAAV stability upon stress and storage.

Abstract: Methods for identifying viral protein constituents and quantifying the relative abundance of such viral protein constituents in a sample of viral particles are disclosed. In embodiments, the methods include first-dimension chromatography to separate intact viral capsid components of the sample, online denaturation of the viral capsid components to produce intact viral proteins, second-dimension chromatography to separate the viral proteins, and mass spectrometry to determine the masses of the viral proteins and identify the viral protein constituents of the sample.

Abstract: Methods for determining the relative abundance of intact adeno-associated virus (AAV) capsid components in a sample of recombinant AAV particles are disclosed. In embodiments, the methods include a system regeneration process that minimizes or eliminates the presence of ghost peaks to maximize analytical accuracy and ensure product quality and consistency.