Protein products used as therapeutic agents, such as monoclonal antibodies, recombinant proteins and protein scaffolds, may trigger adverse immune responses in patients, which can produce anti-drug antibodies affecting the biological activity and efficacy of the drug. Therefore, it is crucial to detect immunogenicity risk and design for deimmunization.

Creative BioMart provides immunogenicity-related services, including the characterization of the immunogenicity and the design and manipulation of deimmunization, addressing biotherapeutic immunogenicity issues through the use of strategies that remove T-cell epitopes.

Introduction to Drug Immunogenicity

The immunogenicity risks of biotherapeutics and the potential outcomes for users are broad and varied, but the risk of immunogenicity of drugs can be characterized and evaluated by MHC-related peptide proteomics studies. The key factors of immunogenicity induced by biotherapeutics is T-cell immunity, recognition of MHC-like related peptides by specific T-cell receptors presented by APCs, and activation of CD4⁺ T cells through secretion of related cytokines, which promote B-cell responses and production of high-affinity anti-drug antibodies. Thus, MHC-like related peptides play an initiating role in the immune response, and we can identify and assess the relevant immunogenicity through proteomic studies.

Fig.1 The process of anti-drug antibody production. (Karle A C, 2020)

Based on this mechanism, design operations such as identification, modification, and deletion of T-cell epitopes can be applied to de-immunization during drug development.

Our Services

• Immunogenicity Assessment of Protein Drugs with pMHC. Immunogenicity has become a key factor limiting the therapeutic efficacy of protein drugs and affecting product safety, making immunogenicity risk assessment critical in drug development. We offer immunogenicity assessment services to study drug-specific T-cell responses using pMHC complexes to ensure maximum efficacy and optimal safety of protein products.
• Design of Deimmunized Biotherapeutics. Given the deleterious consequences of the immune response to anti-protein drugs, we need to assess and mitigate the risk of immunogenicity if we are to make the most of these powerful drugs. We provide solutions for inducing tolerance to therapeutic proteins using strategies and technologies that de-immunize biotherapeutic proteins, going on to assist pharmaceutical companies in developing powerful new drugs.

Applications

• Select biologic therapy candidates by testing immunogenicity risk ranking. We apply MHC peptidomics analysis and T-cell assays to show drug immunogenicity, providing useful information for ranking similar drug candidates in the drug development process.
• Design for deimmunization in drug development. We can identify and remove potentially presenting immunogenic antigenic peptides by identifying the peptide sequences of different biotherapeutics through a high-throughput technology platform.

Creative BioMart possesses a unique technique for MHC-related peptide studies, supporting candidate sequencing and selection during early drug design and potentially contributing to the development of drug products with lower immunogenicity.

If you are interested in our services, please feel free to contact us by phone or email and our technical support staff will get back to you as soon as possible. We look forward to working with you! Please contact us to help your pharmaceutical project run smoothly.

Reference

• Karle A C. "Applying MAPPs Assays to Assess Drug Immunogenicity." Frontiers in Immunology (2020),11,698.