Regeneron Pharmaceuticals, Inc.
CHARACTERIZATION OF IMPURITIES IN ADENO-ASSOCIATED VIRUS (AAV) SAMPLES AND FORMULATION COMPOSITIONS TO STABILIZE AAV

Abstract:

Methods for characterizing DNA impurities in adeno-associated virus (AAV) samples or biopharmaceuticals are provided including the use of size exclusion chromatography and spectrophotometry. Methods and compositions are also provided to minimize leakage of packed DNA from AAV vector including the use of excipients, such as a sugar, an amino acid, a surfactant, or polyols.