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Unwanted Immunogenicity Of Therapeutic Biological Products

July 11, 2007

Unwanted Immunogenicity Of Therapeutic Biological Products

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Unwanted Immunogenicity Of Therapeutic Biological Products

Problems and Their Consequences

Robin Thorpe and Meenu Wadhwa

A recent increase in the occurrence of pure red cell aplasia (PRCA) has sparked new industry and regulatory concern over immunogenicity of therapeutic proteins. Robin Thorpe and Meenu Wadhwa of the National Institute for Biological Standards and Control (United Kingdom), discuss causes and consequences of immunogencity and PRCA, pointing to European Union guidelines that recognize an ongoing need to assess products poslicensing.

Reprinted with permission from BioProcess International 1(9):60-62 (September 2003)

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Unwanted Immunogenicity Of Therapeutic Biological Products

SOURCE: BioProcess International

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