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Related Experiment Video

Updated: May 4, 2026

Author Spotlight: Unveiling the Polyfunctionality and Heterogeneity in Immune Responses
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Cytokine release assays: current practices and future directions.

D Finco1, C Grimaldi2, M Fort3

  • 1Pfizer Worldwide Research and Development, Groton, CT, USA.

Cytokine
|January 14, 2014
PubMed
Summary

Cytokine release assays (CRA) are crucial for assessing biotherapeutic risks post-TGN 1412 incident. This review surveys industry practices, highlighting evolving methods for predicting human cytokine release and ensuring safety.

Keywords:
Cytokine release assayCytokine stormMonoclonal antibodyTGN 1412

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Area of Science:

  • Immunotoxicology
  • Biopharmaceutical Safety Assessment
  • Drug Development

Background:

  • The CD28 superagonist TGN 1412 incident underscored the need for robust cytokine release assays (CRA).
  • CRAs are vital for hazard identification and risk assessment of novel biotherapeutics.
  • Variability exists in CRA strategies, formats, and data interpretation across laboratories.

Purpose of the Study:

  • To provide an overview of diverse CRA approaches used by the pharmaceutical industry and contract research organizations (CROs).
  • To discuss ongoing academic research, the regulatory landscape, and current assay limitations.
  • To offer recommendations for the future development and application of CRAs.

Main Methods:

  • Survey and follow-up conducted by the ILSI-HESI Immunotoxicology Committee CRA Working Group.
  • Review of practices employed by pharmaceutical companies, CROs, academic, and government laboratories.
  • Analysis of data reporting, interpretation, and decision-making processes.

Main Results:

  • Significant variation in CRA methodologies and data utilization exists.
  • Practices are evolving to generate data predictive of in vivo human responses.
  • Regulatory submissions increasingly incorporate CRA data, though standardization is pending.

Conclusions:

  • Standardization of CRA methodologies and data interpretation is needed.
  • Further research is essential to enhance the predictive power of CRAs for clinical safety.
  • Collaborative efforts are crucial for advancing CRA applications in biotherapeutic development.