Immunogenicity Assessment for Advanced Therapeutics

Host immune responses to advanced therapeutics and complex biologics present a persistent challenge to clinical translation. A proactive, modality-specific immunogenicity assessment strategy is required to interpret nonclinical safety data and inform clinical trial design. Applying proven intelligence in high-resolution immune profiling allows sponsor teams to de-risk programs and accelerate timelines toward IND submission.

A standard testing template does not exist for these therapies. The immunogenic potential is dictated by a combination of factors including the delivery vector (e.g., AAV8, AAV9, or engineered capsids), the RNA payload (mRNA, gRNA, saRNA), the manufacturing process, and the patient’s underlying condition. Our approach is to design and qualify assays tailored to the specific needs of your therapeutic program.

Core Immune Profiling Platforms

Our immunology core provides a comprehensive suite of qualified assays to characterize both humoral and cellular immune responses. All methods are developed and validated in a phase-appropriate manner consistent with GxP guidelines.

• Neutralizing Antibody (NAb) Assays: Cell-based and competitive ligand-binding formats to measure functional antibody responses that can impact therapeutic efficacy.
• Anti-Drug Antibody (ADA) Assays: Tiered testing strategies using sensitive platforms like Meso Scale Discovery (MSD) to detect binding antibodies against vectors or transgenes.
• T-cell Response Assays: Functional characterization of cellular immunity using ELISpot to identify and quantify antigen-specific T-cell populations.