Implementing a Clinical Immunogenicity Strategy using Preclinical Risk Assessment Outputs

Vibha Jawa(EpiVax (United States)), Diana Montgomery, Jad Maamary(Immunai (United States)), Shuli Zhang(Kunshan Govisionox Optoelectronic (China)), Michael D. Swanson(Janssen (United States))

Journal of Pharmaceutical Sciences

February 2, 2022

10.1016/j.xphs.2022.01.032

Cited by 18

Related Papers

Molecular Mechanisms of CD200 Inhibition of Mast Cell Activation

|The Journal of Immunology|2004|240

Immunogenicity assessment of AAV-based gene therapies: An IQ consortium industry white paper

|Molecular Therapy — Methods & Clinical Development|2022|113

2020 White Paper on Recent Issues in Bioanalysis: Vaccine Assay Validation, qPCR Assay Validation, QC for CAR-T Flow Cytometry, NAb Assay Harmonization and ELISpot Validation ( <u>Part 3</u> –Recommendations on Immunogenicity Assay Strategies, NAb Assays, Biosimilars and FDA/EMA Immunogenicity Guidance/Guideline, Gene & Cell Therapy and Vaccine Assays)

|Bioanalysis|2021|60

Development of Anti-CD74 Antibody–Drug Conjugates to Target Glucocorticoids to Immune Cells

|Bioconjugate Chemistry|2018|58

Assay format diversity in pre-clinical immunogenicity risk assessment: Toward a possible harmonization of antigenicity assays

|mAbs|2021|57