Preclinical Strategies in Rodent Studies Using Volumetric Absorptive Microsampling (VAMS®)
ISSUE NO. 20 — Validation of Immunogenicity Assays
Regulatory guidelines focusing on immunogenicity assays for clinical studies are not all applicable to nonclinical requirements and their unique challenges. While we have a full understanding of regulatory requirements for clinical studies, the lack of regulatory documents addressing the particular needs of nonclinical immunogenicity studies has contributed to less consensus on appropriate immunogenicity testing strategies and validation parameters. This, by extension, has led to different approaches being adopted by the drug development industry.
In Issue 20 of The Altascientist, we review and share some of Altasciences’ approaches to validating immunogenicity assays for nonclinical and clinical studies, including insight on:
- how to plan for immunogenicity assessments
- drug tolerance
- positive control
- managing variability
- critical reagent validation and changes
- neutralizing anti-drug antibodies (NAbs)
The Next Trip: Developing the Second Generation of Psychedelics and Their Analogs for Targeted Medical Use
Following decades of stagnation, the field of psychedelic research is being revitalized by the investigation of their potential benefit for mainstream psychiat
Method for Surgical Closing of Muscle Biopsy Sites on Nonhuman Primates in Group Housing
Using Anti-Drug-Antibody Screening Assay to Resolve Selectivity Issues in Toxicokinetic Ligand-Binding Assay
Mitigation of On-Column Conversion of Ivabradine to Desmethylivabradine Metal Chelation With Citric Acid Modifier
Dual Purpose of a Cell-Based Assay for an Agonist of the GLP-2 Receptor