Finco, Deborah, Grimaldi, Christine, Narayanan, Padman, Walker, M, Kiessling, Andrea, Wolf, Babette, Salcedo, Theodora, Faggioni, R, Schneider, A, Ibrahimov, A, Scesney, S, Serna, D, Prell, R and Stebbings, R (2014) Cytokine release assays: Current practices and future directions. Cytokine, 66 (2). pp. 143-155. ISSN 1043-4666

Abstract

As a result of the CD28 superagonist biotherapeutic monoclonal antibody (TGN 1412) "cytokine storm" incident, cytokine release assays (CRA) have become hazard identification and prospective risk assessment tools for screening novel biotherapeutics directed against targets having a potential risk for eliciting adverse pro-inflammatory clinical infusion reactions. Different laboratories may have different strategies, assay formats, and approaches to the reporting, interpretation, and use of data for either decision making or risk assessment. Additionally, many independent contract research organizations (CROs), academic and government laboratories are involved in some aspect of CRA work. As a result, while some pharmaceutical companies are providing CRA data as part of the regulatory submissions when necessary, technical and regulatory practices are still evolving to provide data predictive of cytokine release in humans and that are relevant to safety. This manuscript provides an overview of different approaches employed by the pharmaceutical industry and CROs, for the use and application of CRA based upon a survey and post survey follow up conducted by ILSI-Health and Environmental Sciences Institute (HESI) Immunotoxicology Committee CRA Working Group. Also discussed is ongoing research in the academic sector, the regulatory environment, current limitations of the assays, and future directions and recommendations for cytokine release assays. © 2013 Elsevier Ltd.

Item Type:	Article
Additional Information:	this is the follow up of OAK project ID: 5948 (old original input to the manauscript from Novartis)
Keywords:	Cytokine release assay Cytokine storm Monoclonal antibody TGN 1412
Date Deposited:	13 Mar 2018 00:45
Last Modified:	25 Jan 2019 00:46
URI:	https://oak.novartis.com/id/eprint/9407