Protein heterogeneity and the immunogenicity of biotherapeutics

Author(s): Professor Roy Jefferis, PhD, DSc, MRCP, FRCPath

Abstract: High resolution analytical techniques reveal structural micro-heterogeneity within endogenous proteins, however, they are ‘seen’ as ‘self’ molecules by the immune system and immunological tolerance is established. In contrast the protein biotherapeutics are produced in non-human cells and multiple downstream protocols are employed in the isolation and purification of drug product; consequent micro-heterogeneities may be […]

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