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Recombinant Proteins From Plants pp 325–339Cite as

Assessing the Risk of Undesirable Immunogenicity/ Allergenicity of Plant-Derived Therapeutic Proteins

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Part of the book series: Methods in Molecular Biology™ ((MIMB,volume 483))

Summary

Therapeutic proteins have an intrinsic potential to induce undesirable immune and allergic responses. The nature of the expression system and the control of the manufacturing process represent extrinsic factors that could modify this potential. Accordingly, regulatory agencies require sponsors to assess the risk of clinical immune and allergic responses that could be associated with the production of therapeutic proteins in transgenic plants. Since factors related to the clinical use of the product–including the immune status and genetic background of subjects–are also relevant, the risk assessment needs to balance the probability of a response induced by a plant-specific factor relative to the likely consequences for the specific product and therapeutic indication.

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Author information

Authors and Affiliations

  1. bioLOGICA Consulting, France

    Paul D. Chamberlain

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  1. Paul D. Chamberlain
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Editors and Affiliations

  1. CNRS, Université de Rouen, Mont Saint Aignan, France

    Loïc Faye  & Véronique Gomord  & 

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Chamberlain, P.D. (2009). Assessing the Risk of Undesirable Immunogenicity/ Allergenicity of Plant-Derived Therapeutic Proteins. In: Faye, L., Gomord, V. (eds) Recombinant Proteins From Plants. Methods in Molecular Biology™, vol 483. Humana Press. https://doi.org/10.1007/978-1-59745-407-0_19

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  • DOI: https://doi.org/10.1007/978-1-59745-407-0_19

  • Publisher Name: Humana Press

  • Print ISBN: 978-1-58829-978-9

  • Online ISBN: 978-1-59745-407-0

  • eBook Packages: Springer Protocols

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