Immunogenicity Service
CMIC Chicago Immunogenicity
CMIC Chicago Immunogenicity
Immunogenicity is crucial in drug development, especially for large molecule therapeutics. Assessing the immune system’s response to a drug is essential, whether your drug is an oligonucleotide, monoclonal antibody, bispecific, antibody-drug conjugate (ADC), antibody-oligonucleotide conjugate, fusion protein, enzyme, peptide, or gene therapy. CMIC can develop or transfer assays for your immunogenicity program. Key areas of immunogenicity at CMIC:
- Non-Clinical
- Clinical
- Advanced Testing
Non-Clinical Immunogenicity
- Purpose: The main aim of a non-clinical anti-drug antibody (ADA) assay is to interpret pharmacokinetics (PK) for Investigational New Drug (IND)-enabling toxicology studies.
- Approach: CMIC promotes a streamlined, screening-only approach that can be quickly developed and validated, though multiple tiers of testing are available upon request.
- Method Development: Focus on drug tolerance during method development for non-clinical ADA assays.
- Sample Analysis: Rapid timelines for IND submission are critical, and CMIC collaborates to meet these milestones.
Clinical Immunogenicity
- Patient Safety: Safety is paramount in clinical immunogenicity. The necessity of a neutralizing antibody (NAb) or specificity assays should be based on a risk assessment of the drug and patient population.
- Comprehensive Services: CMIC provides services for binding ADA (including screening, confirmatory, and titer tiers of testing), neutralizing antibody assays, and isotype/domain specificity for complex biotherapeutics.
- Regulatory Standards: Clinical ADA assays are validated to the latest standards, focusing on acceptable sensitivity, drug, and target tolerance.
- Control Monitoring: Low positive controls are set statistically and monitored throughout the study lifecycle.
- Predose Sample Assessment: Continual assessment of predose sample results ensures cut points are appropriate for the study population
Advanced Testing
- Multi-Domain Therapeutics: Specificity testing can determine which domain antibodies target. Isotype-specific assays can distinguish between IgG, IgM, IgA (for inhaled/oral therapeutics), or IgE (when anaphylaxis is a concern).
- Neutralizing Antibody Assays: These assays show whether antibodies impact drug functionality and can be challenging to develop. CMIC’s scientists are skilled in developing and validating these assays, understanding the precision, sensitivity, and drug tolerance issues they may present.
- Alternative Assay Types: Receptor binding assays or enzyme assays may assess drug function neutralization. CMIC advises on suitable assay types and includes pre-treatment strategies to improve drug tolerance or eliminate matrix interference.