Creative Biolabs provides detection and characterization assays for anti-drug antibodies (ADAs) of biotherapeutic drug candidates. Following the current FDA and EMEA guidelines and AAPS white papers, Creative Biolabs has developed many approaches to detect the ADA responses by using a variety of leading instrumentation platforms, such as ELISA/RIA, surface plasmon resonance (SPR) and electrochemiluminescence (ECL).
Arising of anti-drug antibodies (ADAs) against biotherapeutic drugs has been widely observed in clinical applications, such as anti-TNF adalimumab, recombinant Factor VIII, and interferon beta. ADAs have been associated with the reduced clinical efficacy of biotherapeutic drugs as well as a variety of potentially serious clinical adverse effects. ADAs can be classified into two categories, neutralizing ADAs (NAbs) that block the binding of biotherapeutic drugs to their targets, and non-neutralizing ADAs (non-NAbs) that mainly contribute to faster clearance and drug resistance. ADAs have also been linked with increased side effects, such as infusion reactions and even life-threatening auto-immune syndromes caused by the cross-reactivity of ADAs with endogenous proteins. Therefore, evaluation the ADA reactions against biotherapeutic drugs in both preclinical and clinical studies is of great value for efficacy optimization and risk management of biotherapeutic drug candidates, which is required for IND application at the same time.
Bridging ELISA for ADA testing.
With more than ten years’ experience in providing excellent services for researchers in both academia and biopharmaceutical industry, Creative Biolabs is an experienced expert on ADA assay development and validation. We strive to accelerate the development of your new drug candidate from preclinical to clinical stage and eventually to the market. Our SIAT® anti-drug antibodies assay services include but not limit to the following.
Positive control and reagent formation
Before ADA assays, suitable positive controls must be obtained. We can prepare polyclonal or monoclonal antibody against the active ingredients that are similar to the actual ADA samples. In addition, drugs labeled with biotin or fluorescent tags can be synthesized.
Assay method development & validation
We will develop proper assays based on currently used ones such as “Bridging”, direct or competitive ELISA, cytokine profile, sensitivity, specificity, and precision evaluation and stay in compliance with FDA and EMEA guidelines and AAPS white papers.
Characterizations of ADAs include the titer, isotype of ADAs, and detection of neutralization status of the ADAs. A general problem with ADA assays is the formation of drug-ADA complexes in the sample. We have developed several approaches such as pre-incubation with ADA assay reagents and acid dissociation to solve this problem.
Pharmacokinetic /Toxicokinetic (PK/TK) analysis
Evaluation of possible changes in PK/TK that are induced by ADAs.
More SIAT® Immunogenicity Related Services at Creative Biolabs
In Silico Immunogenicity Assessment
In Vitro Class II HLA Binding Assay
Ex Vivo Immunogenicity Assessment
DC-T Cell Proliferation Assay
Antigen Presentation Assay
In Vivo Immunogenicity Assessment
Anti-drug Antibodies (ADA) Assays