Most of the antibody drugs that have been approved or are undergoing clinical trials have immunogenicity to varying degrees. Generally, there are many internal and external factors that may cause or affect the immunogenicity of antibodies. Aggregation, adjuvant like pollutants, the combined use of drugs, co-medication of the patient, and in some cases the release of cytokines are called exogenous factors. The main intrinsic factors that influence or induce the immune response of therapeutic antibodies include specific carbohydrate side chains that exist in variable and constant regions through glycosylation sites. In addition, immunogenicity is also influenced by other post-translational modifications of antibodies, such as glycosylation, deamidation, and oxidation of amino acid side chains.
A large number of studies have shown that the presence of CD4+ T helper cell epitopes in injection molecules is one of the factors related to the improvement of the antibody-drug immune response. Therefore, a group of major engineering effects on antibody molecules is aimed at limiting its immunogenicity by reducing its non-human sequence content (chimerism and humanization) or by de-immunization, including the recognition and removal of T cell epitopes.
Fig.1 An example model for de-immunization. (Ducancel, 2012)
Creative Biolabs provides RDIT® de-immunization service for antibody drugs in combination with our RDIT® Immunogenicity Assessment Platform. It adopts a novel, innovative and classic methods to reduce the immunogenicity of candidate drugs by combining immunology and molecular biology technology. With rich experience and deep professional knowledge, we will provide great help for your potential drug candidates to enter clinical trials. Alternative technologies include:
Our services have been widely used to remove T cell epitopes from biotherapy drugs while maintaining their therapeutic efficacy. The following is a brief description of the workflow of our de-immunization service for antibody drug candidates.
Creative Biolabs tailor services to each project to ensure that goals are met or exceeded. Experienced project teams are assigned to each study to focus on the progress of the project in order to achieve results in the shortest time. Please contact us for more information, a quote or to schedule a conference call.
All listed customized services & products are for research use only, not intended for pharmaceutical, diagnostic, therapeutic or any in vivo human use.