Immunogenicity is a major problem with protein-based therapeutics due to circulating anti-drug antibody (ADA) production. ADA may lead to many clinical problems including allergic reactions, altered pharmacokinetic, reduced efficacy, etc. Thus, perform an immunogenicity testing to evaluate the ADA level induced by therapeutic protein drug is a necessary step in both clinical studies and post marketing clinical monitoring.

All-Stage ADA Assay Development Service Details
At Creative Diagnostics, we are available in providing all following services at All Stages of immunogenicity assay development process:

Development of Positive Control Reagent
Developing a specific antibody as positive control is recommended to monitor the immunogenicity of the candidate drugs. Creative Diagnostics is experienced in antibody development and we can custom the most suitable antibodies as positive control according to target product.

The development of ADA involves multiple immune system processes: Exogenous drugs like recombinant proteins and monoclonal antibodies are captured by antigen-presenting cells (APCs) before they are transferred to T cells through the major histocompatibility complex (MHC) pathway. When CD4 T cells identify an antigen, they release cytokines which activate B cells. Activated B cells produce specific antibodies known as ADA when they mature into plasma cells.

The ADA antibody produced by activated B cells combines with the medication to create immunological complexes which result in adverse immune responses. The formation of these complexes affects how the drug distributes within the body and how it gets metabolized as well as the patient's ability to tolerate the therapy.