Immunogenicity Prediction
Immunogenicity is the most critical safety issue associated with biologics. Immunogenicity is the ability to induce humoral and/or cell-mediated immune responses. Most biologics induce immune responses because they are polypeptides or proteins and thus can be recognized by the immune system as foreign objects. Given that biologics may induce this unwanted immune response; it is important to study the immunogenicity of biological agents prior to marketing approval.
To help you understand and address the potential issues of drug immunogenicity in your program at any stage, Creative Biolabs has developed Sensitive Immunogenicity Assessment Technology (SIAT) according to specific FDA and EMA guidelines. SIAT-based highly sensitive and unique assessment techniques include in silico assessment and in vitro screening, which are effective in a wide range of applications, including biopharmaceutical quantification, anti-drug antibody (ADAs) assays, and pharmacokinetic / pharmacodynamics efficacy measurements.
In Silico Assessment - T Cell Epitope Screening
Driven by sequencing technology, structural bioinformatics and experimental data analysis, Creative Biolabs has developed the SIAT-based in silico assessment technology, a proprietary T cell epitope screening tool for identifying potential epitopes in biotherapeutic proteins and new antibody targets. The in silico tool predicts potential peptide/HLA binding by mimicking the structural features of the MHC class II and experimentally determines binding affinity, which are prerequisites for T cell activation.
In Vitro Screening
Creative Biolabs’s in vitro platform assesses the immunogenicity risk of biologics by directly measuring immune responses using peripheral blood mononuclear cells (PBMCs). When combined with our in Silico tool, these cell analyses allow for a complete immunogenic risk assessment of your primary lead candidate. In vitro assays include: 
In Vivo Screening
In vitro and ex vivo assays provide a direct preview of the immunogenicity of biotherapeutic drug candidates, but these assays have some limitations. Creative Biolabs also offers a one-stop in vivo immunogenicity assessment service, which uses a variety of animal models, including HLA transgenic mice and humanized mice, to provide the most direct assessment of the molecules before entering clinical trials.
Creative Biolabs' SIAT-based in silico services and in vitro screening provide the most comprehensive immunogenicity assessment package, which addresses the challenges of unwanted immune responses throughout the drug development cycle. By managing potential drug immunogenicity at the earliest possible stage, you can save time and money while creating safer and more effective biotherapeutic drugs for the market.
Our Good Laboratory Practice (GLP)-compatible labs are designed to meet the large-scale bioanalysis for your project, and our dedicated biologics team works with you to tailor your assessment strategy to your treatment goals and schedule using a full suite of immunogenicity assessment package.
To obtain further information, please contact us.
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