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Unwanted Immunogenicity: Implications for Follow-on Biologicals

  • Drug Development
  • Continuing Education
  • Published:
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Abstract

The unexpected and unpredictable development of unwanted immunogenicity is a significant issue affecting therapeutic proteins, including follow-on biologicals. The development of antibodies against the therapeutic biological can cause allergic or anaphylactic reactions, reduction in efficacy, and, in some cases, severe adverse effects. The risk of inducing immune responses is largely dependent on the recipient as well as a number of product-related factors (eg, production process, formulation, and number of doses administered during the course of treatment). Consideration should be given to the evaluation of unwanted immunogenicity of follow-on biologicals from preclinical development, through clinical trials, and into the postregistration period to minimize the risks associated with immunogenicity in recipients of therapeutic products. Properly planned immunogenicity studies during phase I/II clinical trials using a range of carefully validated procedures are needed to assess unwanted immunogenicity of therapeutic products.

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Authors and Affiliations

  1. Division of immunology and Endocrinology, National Institute for Biological Standards and Control (NIBSC), Blanche Lane, South Mimms, Potters Bar, Hertfordshire, EN6 3QG, UK

    Meenu Wadhwa BSc, PhD (Principal Scientist) & Robin Thorpe BSc, PhD, FRCPath (Head)

Authors
  1. Meenu Wadhwa BSc, PhD
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  2. Robin Thorpe BSc, PhD, FRCPath
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Corresponding author

Correspondence to Meenu Wadhwa BSc, PhD.

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The Drug Information Association is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. This program is designated for a maximum of I contact hour or . I continuing education units (CEUs). 286-000-07-40-H1 04.

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Wadhwa, M., Thorpe, R. Unwanted Immunogenicity: Implications for Follow-on Biologicals. Ther Innov Regul Sci 41, 1–9 (2007). https://doi.org/10.1177/009286150704100102

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