Cell-Based Assays for Immunogenicity and Immunotoxicity
Types of assays that investigate innate immunity include uptake, digestion and presentation of biotherapeutic product by antigen presenting cells (APC) like dendritic cells in conjunction with class II HLA molecule.
This guidance provides recommendations to facilitate industry’s development and validation of assays for assessment of the immunogenicity of therapeutic protein products during clinical trials.
Immunoassay Methods - Assay Guidance Manual - NCBI Bookshelf
2012年5月1日 · Immunoassays are used to quantify molecules of biological interest based on the specificity and selectivity of antibody reagents generated. In HTS and lead optimization projects, assays are designed to detect molecules that are produced intracellularly or secreted in response to compounds screened.
18 immune assays for assessment of the immunogenicity of therapeutic protein products during 19 clinical trials. Specifically, this document includes guidance regarding the...
2024年1月31日 · Immunogenicity Assay Strategy • Autologous T cells pose low to medium immunogenicity risk but can induce both innate and adaptive immune responses • Cell therapies are capable of inducing both humoral and cellular responses • Overall strategy is similar to large molecules and large molecule guidelines are applicable
• As antibody assays improve in sensitivity we encounter detection of low level endogenous antibodies capable of binding to drug • Important to have assays sensitive to detect earliest indication of an immune response • Must be able to discriminate clinically relevant antibodies
Immunogenicity Testing Services | Charles River
Our immunogenicity testing services allows you to establish the immune response to your compounds at the anti-drug antibody (ADA assay) or neutralizing antibody (nAb assay) level.
This guideline replaces ‘Guideline on Immunogenicity assessment of biotechnology-derived therapeutic proteins’(EMEA/CHMP/BMWP/14327/2006). European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged. 4.1.
For Immunogenicity Assays: Immunogenicity Testing of Therapeutic Protein Products — Developing and Validating Assays for Anti-Drug Antibody Detection (February 2019)
Validation of a nonclinical immunogenicity assay at Altasciences is comprised minimally of the screening assay, with the option to include either the titration and/or the confirmation assay, depending on project needs. The validation is tailored to support the needs of a nonclinical study.