Anti-Drug Antibodies Assay Development Service

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.

Clinical problems with immunogenicity:

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

Thus, perform an immunogenicity testing to evaluate the ADA level induced by therapeutic protein drug is very necessary in both clinical studies and post marketing clinical monitoring. The evaluation of ADA is a multi-step analytical approach including a broad range of different assay formats and methodologies.

A complete analytical assessment of ADAs includes the following steps: screening assay, confirmatory assay, titration assay and neutralization assay.

  • Screening Assay——Detect unique ADAs in patient samples
  • Confirmatory Assay——Confirm the drug specificity of ADAs
  • Titration Assay——ADAs Characterization
  • Neutralization Assay——ADAs Characterization

Creative Diagnostics provides complete, highly-sensitive, highly-selective ADA Assay Kit Development Service which is suitable in various product types:

  • Peptide
  • Recombinant protein
  • Therapy mAb
  • Bi-specific antibody
  • ADC
  • Biosimilar
  • PEGylated protein
  • CAR-T

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:

  • Development of specific antibodies
  • Reagent preparation
  • Development and optimization of ADA screening and confirmatory assay
  • Titration and isotyping
  • Neutralization assay

Features of our Services:

  • Full-scale ADA assays with high sensitivity
  • Competitive price with high quality
  • High-efficiency with short turnaround time
  • Professional technical team with scientific program

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.

Related service:

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

  1. Food and Drug Administration (2016). Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products (Guidance for Industry).
  2. Food and Drug Administration (2014). Immunogenicity Assessment for Therapeutic Protein Products (Guidance for Industry).

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