Recommendations for the characterization of immunogenicity response to multiple domain biotherapeutics

2014/05/24 by Boris Gorovits, Eric Wakshull, Renuka Pillutla +3 · 15 citations
Medicine · Immunology and Microbiology · #Monoclonal and Polyclonal Antibodies Research #Biosimilars and Bioanalytical Methods #CAR-T cell therapy research

paper · doi:10.1016/j.jim.2014.05.010

Citations

• Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products
• Recommendations on risk-based strategies for detection and characterization of antibodies against biotechnology products

Cited by

• Development of a Generic Anti-PEG Antibody Assay Using BioScale's Acoustic Membrane MicroParticle Technology. [europepmc]
• Application of a Plug-and-Play Immunogenicity Assay in Cynomolgus Monkey Serum for ADCs at Early Stages of Drug Development. [europepmc]
• Investigation of pre-existing reactivity to biotherapeutics can uncover potential immunogenic epitopes and predict immunogenicity risk. [europepmc]
• Considerations for the Design of Antibody-Based Therapeutics. [europepmc]
• A Tiered Approach for Characterization to Ensure Quality, Reproducibility, and Long-Term Stability of Critical Reagents in Regulated Bioanalysis to Support PK/ADA/NAb Assays for Biologics and Vaccines Programs. [europepmc]
• Anti-drug Antibody Validation Testing and Reporting Harmonization. [europepmc]
• Immunogenicity assessment of bispecific antibody-based immunotherapy in oncology. [europepmc]
• Integrated summary of immunogenicity of polatuzumab vedotin in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma. [europepmc]
• The MHC Associated Peptide Proteomics assay is a useful tool for the non-clinical assessment of immunogenicity. [europepmc]
• T and B cell epitope analysis for the immunogenicity evaluation and mitigation of antibody-based therapeutics. [europepmc]
• Unique challenges required reassessment and alterations to critical reagents to rescue a neutralizing antibody assay. [europepmc]
• Critical reagent considerations for immunogenicity assay development for bispecific biotherapeutic candidates. [europepmc]
• Immunogenicity assessment strategy for a chemically modified therapeutic protein in clinical development. [europepmc]
• Singlicate analysis in ADA assays: comparing assay performance in duplicate and singlicate formats. [europepmc]
• Heterogeneous and evolving epitope landscape of clinical anti-drug antibodies against multidomain biotherapeutic: a case study of TAK-186. [europepmc]