Immunogenicity testing is an essential step in therapeutic protein drug development process. Anti-Drug antibodies (ADA) may lead to many clinical problems including allergic reactions, altered pharmacokinetic, reduced efficacy, etc.
Thus, immunogenicity testing to evaluate the ADA level induced by therapeutic protein drug is very necessan in both clinical studies and post marketing clinical monitoring.The evaluation of ADA employs a multi-tiered analytical approach including a broad range of different assay formats and methodologies.
| Clinical Concerns | Clinical Outcome |
| Safety | Hypersensitivity reactions； Deficiency syndrome |
| Efficacy | Enhancing or decreasing efficacy by： Changing half-life； Changing biodistribution |
| Pharmacokinetics（PK） | Changes to PK； Changes to PD |
| Others | Despite generation of antibodies, no discernable impact |
A complete analytical assessment of ADAs includes the following steps: screening assay, confirmatory assay, titration assay and neutralization assay.
In addition to the standard multi-tiered testing, auxiliary characterization can be performed at client's request, such as epitope mapping, isotyping, and cross-reactivity assessment.
Creative Diagnostics provides complete, highly-sensitive, highly-selective ADA Assay Kit Development Service which is suitable in various product types:
The common methods we offer for ADA screening and confirmatory assay are listed as follow:
| Format | Advantage | Disadvantage |
| Bridging/Direct ELISA | Low cost, high flux and wide application | Limited sensitivity |
| MSD | Multi-factor detection, high flux, high sensitivity | High cost, Limited availability |
For neutralization assay, cell-based assays we take are able to produce results that are more biologically relevant or have physiological relevance, which is a regulatory authorities' preferred method to detect NAb presence. Our extensive cross-platform experience allows to develop cell proliferation, gene expression, gene reporter, antibody-dependent cell-mediated cytotoxicity (ADCC), and complement dependent cytotoxicity (CDC) assays with high specificity, sensitivity, and precision.
Creative Diagnostics has years of experience in designing, optimizing, and validating ADA assays for biotech and pharma companies. Our veteran scientists are able to design scientific and appropriate assay format and optimum proposal for different products.
Our team can provide all the following services at all stages of the immunogenicity assay development process:
Our assay kit development is surely up to the FDA standard and we can tailor our protocols in every major step of the assay development to fit your specific purposes. We are glad to make it accessible to all kinds of research and industrial clients. If you are interested in the service we provide, please feel free to contact us for more information. We are looking forward to working with you.
Antibody Custom Services suitable for ADA assay
| Options | Antibody types | Time | Epitope | Characteristics | Remark |
| 1 | Affinity purified rabbit pAb | 10-12 weeks | Multiple | Good specificity; High sensitivity; Low cost; Short-time; Batch variation | Recommended |
| 2 | Mouse mAb | 26-29 weeks | Single | High specificity; Minimal batch variation; Lower sensitivity; High cost; Long-time | Multiple mAbs are recommended |
| 3 | Rabbit mAb | 25-37 weeks | Single | High specificity; Minimal batch variation; Lower sensitivity; High cost; Long-time | Multiple mAbs are recommended |
| ... | Custom appropriate antibodies to fit you need | ||||
Reference
