BioPharma Services >> Bioanalysis >> Immunogenicity

Immunogenicity

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The development and validation of immunogenicity assays is under constant discussion within the industry. Our GLP-compliant service laboratories are involved in international workshops and has R&D programs to keep ahead of the latest developments in this area, so that we can best help our customers to accelerate their drug  discovery and development programs. Adhering to current FDA and EMEA guidelines and AAPS white papers, we follow a stepwise approach to measure ADA responses using ELISA/RIA, surface plasmon resonance (SPR, Biacore®), electrochemiluminescence (ECL), DELFIA and cell-based NAB-assays.

Biopharmaceuticals, such as antibodies, peptides and recombinant proteins, have the potential to induce an anti-drug antibody (ADA) response. The development of ADA can cause allergic or anaphylactic reactions, reduction in efficacy, or induction of autoimmunity.

Factors affecting immunogenicity include:

  • Similarity to self proteins
  • Glycosylation status
  • Excipients
  • Route of administration
  • Dosing schedule
  • Target

In non-clinical studies, development of ADA can affect drug exposure and impact on data from toxicity, pharmacokinetic (PK) or pharmacodynamic (PD) studies. In clinical studies, development of ADA can be associated with a variety of potentially serious clinical side effects as well as a loss of drug  efficacy. Adhering to current FDA and EMEA guidelines and AAPS white papers, we follow a stepwise approach to measure ADA responses using a variety of leading instrumentation platforms.

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Eurofins Bioanalytical Services offers a comprehensive suite of capabilities to match any scale of immunogenicity project.

 

Method Transfer

Transfer and optimization of non-validated or validated client-developed assays.

Method Development

To provide the best analytical solution for the broadest range of matrices and species, we:

  • Develop and validate assays that have analytical ranges appropriate for what is expected in the study samples
  • Develop assays that are both  specific and sensitive
  • Provide support for adaptation of any commercially available reagents or critical reagent generation and purification including the generation of antibodies to be used for capture or detection reagents
  • Assess method feasibility in multiple technology platforms
 

Validation

Validation of analytical methods is crucial in generating data to be used in support of regulatory submissions. Following the most up-to-date industry guidelines, we offer a fully consultative and comprehensive assay validation or cross-validation service. We validate using a fit-for-purpose approach as appropriate for the nature of the assay well as the stage in drug development.

Sample Analysis

Using the latest industry guidance we apply a tiered immunogenicity testing methodology accompanied with statistical data analysis & support. The steps we use to measure ADA are:

  • Screening assay
  • Confirmatory assay
  • Neutralization assay
  • Characterization assays (isotype, affinity, etc.)