Anti-Drug Antibody / Immunogenicity ELISA

The number of biotherapeutics already approved and in the pipeline have significantly increased in the last decade. With several expiring patents each year, biosimilars and bio-generics are also gaining much ground. However, despite providing significant benefits to patients, almost all biotherapeutics could induce unwanted immunogenicity and developing of anti-drug antibodies.

Immunogenicity testing measures any adverse immune response generated by a biologic such as reduced efficacy or auto-immune, allergic, and anaphylactic reactions in the body.

Immunogenicity ELISA are used during clinical and preclinical studies evaluate the tendency of biologics to produce an immune response in the form of ADAs and nAbs. Immunogenic response against biologics and therapeutic proteins is a common concern for scientists and clinicians focused on drug development. These responses could result in adverse clinical events due to the inactivation of drug therapy for patients. Several factors determine whether any biologic does or does not evoke an immune response, including drug structure, variants, immunogenic status, dosage, route of administration, and genetic profile of treated patients. The overall purpose of immunogenicity study, Anti-Drug Antibody ELISA specifically, is to determine whether ADA antibodies are generated and can cause adverse events or loss of efficacy.

A suitably developed anti-drug antibody ELISA reliably measures and validates immunogenic responses in a variety of biological matrices for your regulatory filing.

KRISHGEN offers highly specific, high affinity Immunogenicity assays including Anti-Drug Antibody ELISA for 30+ targets and several mAb assays, to analyze your novel compounds in clinical and preclinical studies.

Performance Characteristics and Validation Information:

Sensitivity:
The limit of detection is defined as the lowest detectable concentration corresponding to a signal of Mean of ‘0’ standard plus 2* SD. Each kit mentions sensitivity in the datasheet.

Calibration: The Standards provided in the kit are also calibrated against commercially sourced innovator drugs and / or biosimilars. In case where no commercial innovator drugs are available, the kits have been validated using research grade fusion proteins recombinantly expressed.

Recovery and Matrix Effect: The kits have been optimized at specific dilution to ensure optimal noise:signal ratios. Please do not change the dilution of samples recommended in the IFUs. For any queries, please connect with us directly.

Precision: Precision is defined as the percent coefficient of variation (%CV) i.e. standard deviation divided by the mean and multiplied by 100. Assay precision was determined by both intra and inter assay reproducibility on two pools with low, medium, and high concentrations. While actual precision may vary from laboratory to laboratory and technician to technician, it is recommended that all operators achieve precision below these design goals before reporting results.

PoolIntra Assay %CVInter Assay %CV
Low<10%<10%
Medium<5%<5%
High<5%<5%
Quantitative ELISA for ADA

Krishgen’s ELISA for Anti-Drug Antibody estimation is quantitative and comes with lyophilized standards for accurate estimation of the level of antibodies. This allows researchers and clinicians to have additional perspective for alterations to dosage regimens.

Custom Services

Looking for an ADA ELISA that is specific for your needs? Perhaps you require a hypersensitive assay, or one that offers a wider range. Or, you are looking to screen antibodies in an animal sample. Krishgen can customise your assay for you. Learn more about our custom assay services here.

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Data Reduction: We typically use linear graphs and 4PL (2nd order) as the data reduction method. Cubic spline is also recommended in our IFUs. Our typical graph shows the graph in 4PL and also indicates the R2 value with the trend line shown.

Anti-Drug Antibody / Immunogenicity ELISA

Predicting and managing immunogenicity is a key focus of pharmaceutical and biotechnology companies. Emerging approaches aim to predict, reduce, or reverse the immunogenicity of biotherapeutics.

ADAs can bind to drug molecules and form immune complexes, which can reduce the concentration of the active drug in circulation and interfere with its target engagement. This interaction between ADAs and drugs can lead to decreased drug efficacy and potentially increase the risk of adverse reactions. ADA have been observed in preclinical and clinical studies resulting in significant changes in toxicology, pharmacokinetics, and efficacy.  Adverse immunological reactions may vary widely for a drug, depending on how the active ingredients are structured, produced, and applied. Pharmacokinetic studies offer some insight into the behavior of the drug, but anti-drug antibody screening and estimation allows for better understanding of the efficacy.

There are several strategies in place to minimize ADA development:

1. One of the key strategies to minimize ADA development is to assess the immunogenicity risk of a drug candidate early in the drug development process. By utilizing predictive immunogenicity tools and conducting preclinical studies, researchers can identify potential immunogenic epitopes and assess the likelihood of ADA formation. This enables the selection of drug candidates with lower immunogenic potential.

2. Optimization of Drug Design: Optimizing the design of the drug molecule can help minimize ADA development. This includes reducing the presence of structural motifs known to be immunogenic, such as T-cell epitopes. Utilizing protein engineering techniques, such as site-directed mutagenesis or antibody humanization, can help mitigate the immunogenicity risk. Rational drug design approaches can also be employed to improve the binding affinity with the target, reducing the required drug dose and exposure time, which in turn can lower ADA formation.

3. Formulation and Delivery Optimization: The formulation and delivery method of a drug can impact its immunogenicity potential. By selecting appropriate excipients and delivery systems, researchers can enhance drug stability and reduce interactions with immune cells. Additionally, optimizing the route of administration can help minimize local immune responses and subsequent ADA formation.

4. Clinical Trial Design and Patient Monitoring: During clinical trials, it is important to monitor patients for the development of ADAs. Designing clinical trials with appropriate patient selection criteria, including screening for pre-existing antibodies, can help identify patients who may be at a higher risk of developing ADAs. Ongoing monitoring of ADAs during the trial can help assess the impact on drug efficacy and safety. This information can be used to optimize dosing regimens or consider other interventions, such as immunomodulatory agents, to prevent or mitigate the impact of ADAs.

By employing these strategies during drug development, researchers can minimize the development of ADAs, enhance the efficacy of therapeutic interventions, and improve patient outcomes. Including this information on your landing page will showcase your commitment to developing safe and effective drugs while addressing the challenges associated with ADA development.

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Require a Custom Assay?

Krishgen can develop and manufacture to your specific requirements.

Whether you require a change in the assay range or sensitivity, want an assay validated for a specific matrix or even want an novel immunoassay developed, the Krishgen team can support you. Get a free technical consultation to learn about the feasibility and timeline of your new assay.

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