18745346. HOST CELL PROTEIN ANALYSIS FOR ADENO-ASSOCIATED VIRUS (AAV)-BASED GENE THERAPY (Regeneron Pharmaceuticals, Inc.)
Contents
HOST CELL PROTEIN ANALYSIS FOR ADENO-ASSOCIATED VIRUS (AAV)-BASED GENE THERAPY
Organization Name
Regeneron Pharmaceuticals, Inc.
Inventor(s)
Mengqi Hu of White Plains NY (US)
HOST CELL PROTEIN ANALYSIS FOR ADENO-ASSOCIATED VIRUS (AAV)-BASED GENE THERAPY
This abstract first appeared for US patent application 18745346 titled 'HOST CELL PROTEIN ANALYSIS FOR ADENO-ASSOCIATED VIRUS (AAV)-BASED GENE THERAPY
Original Abstract Submitted
The present invention provides methods for identifying, quantifying, and/or characterizing at least one host cell protein (HCP) impurity in a sample containing AAV vectors. The HCP impurities can be enriched through a differential digestion, maintaining intact capsids while exposing the sample to mild denaturation. The mildly denatured sample can subsequently be subjected to enzymatic digestion, generating peptides which can be identified and quantified by liquid chromatography-mass spectrometry (LC-MS) analysis to identify, quantify and/or characterize said at least one HCP impurity.
