The immunogenicity of biotherapeutic drugs is a significant problem during clinical applications. Many biotherapeutic drugs can develop unwanted immune responses in patients such as generation of anti-drug antibodies (ADAs), which results in treatment resistance and potentially life-threatening adverse effects. Although different techniques, including advanced technologies for the expression, purification and formulation of recombinant proteins, and the use of purely human or humanized proteins, have been developed to reduce the immunogenicity of biotherapeutic drugs, the problems remain to be completely eliminated. For instance, fully human antibodies, produced by phage display technology or transgenic mice, may still show degrees of immunogenicity.
Creative Biolabs offers SIAT® de-immunization service in conjunction with our SIAT® Immunogenicity Assessment Platform to assist our clients in reducing immunogenicity of biotherapeutic drug candidates. Our service has been widely used to remove the T cell epitopes from biotherapeutic drugs while preserving their therapeutic efficacy. The knowledge that backs up our de-immunization service is that helper-T cell response is necessary for the development of long-term humoral and cellular immunity.
We employ novel, creative and classic methods to decrease the immunogenicity of drug candidates through the combined use of immunological and molecular biology techniques. Our experienced scientists have established a systematic process for the development of a de-immunized antibody for production in various expression systems. With a wealth of experience and profound expertise, we will be of your great assistance for the advancement of your promising drug candidate into clinical trials. Below is a brief description the workflow of our de-immunization service for biotherapeutic drug candidates.
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