Comprehensive Immunogenicity Assays and Testing Solutions

IMMUNOGENICITY TESTING CAPABILITIES

Whether you're developing a vaccine, biologic or gene therapy, immunogenicity serves as an important assessment. It gauges the antibodies produced in response to your drug, helping you confidently determine efficacy and safety

We provide the following:

1. bioanalysis to support preclinical and clinical immunogenicity studies: qualified versus fully validated methods;
2. bridging ECL assay and direct ELISA assay;
3. experience with interference issues, mitigation strategies, and/or binding components;
4. acid dissociation, SPEAD, ACE, PandA;
5. physical separation by size exclusion or magnetic protein A/G + L;
6. in-house labeling of antigen with biotin and sulfo-TAG;
7. positive control generation service;
8. statistical analysis supported by biostatisticians; and
9. validations per the 2019 FDA guidance.

We have experience with:

1. drug-mAb, PEGylated proteins, endogenous analogs, peptides, fusion proteins, oligonucleotides, gene therapy, ADCs, PDC, bispecifics, and more;
2. interference issues from the drug, drug target and/or binding components, and various mitigation strategies;
3. pre-existing antibodies—the appropriate cut-point approach will be determined based on the prevalence and magnitude of responses;
4. positive control generation and characterization, mAb, and polyclonal sera;
5. several study populations: healthy and patient (immuno-oncology, oncology, malabsorption disorder);

Assay Types

Our team has extensive experience developing and validating a wide range of characterization assays, including assessment of cross-reactivity to endogenous proteins. In addition to being able to titrate your samples, we can also support binding specificity assessment, isotype determination and perform NAb assays, like competitive ligand binding or NAb cell-based assays, depending on the mechanism of action of your drug.