Development and implementation of an LC-MS-based multi-attribute method for adeno-associated virus.

ABSTRACT: The multi-attribute method (MAM), a mass spectrometry technique for quantifying amino acid modifications at the peptide level, is becoming a prominent analytical tool in the development of biotherapeutics. The method has promise for adeno-associated virus (AAV) therapeutics, where capsid protein modifications have been directly linked to reduced transduction efficiency. Given this link, a robust and precise procedure to quantitate capsid modifications would be beneficial for implementation throughout biotherapeutic development. Herein, an AAV product was characterized, and capsid sequence liabilities were identified. A peptide map MAM method was developed to quantitate select sites of modifications and was validated according to ICH Q2(R2). Through this exercise, the method was demonstrate

SUBMITTER: Powers TW 

PROVIDER: S-EPMC12410397 | biostudies-literature | 2025 Sep

REPOSITORIES: biostudies-literature