2-D Electrophoresis and Western Blotting

Why should I consider 2-D electrophoresis and western blotting to evaluate antibodies used in host cell protein ELISA/immunoassay?
  • Per ICH Q6B guidelines, the polyclonal antibodies used must be capable of detecting a wide range of protein impurities
  • According to the FDA, the antiserum needs to be validated via 2-D electrophoresis and western blotting, or similarly sensitive and discriminating techniques in consultation with the agency, for its ability to detect potential HCP impurities

The combination of 1-D electrophoresis and western blotting is not sufficiently informative for this purpose.