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SIAT ® Immunogenicity System

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Creative Biolabs offers comprehensive immunogenicity assessment services for biotherapeutic drug candidates. Relying on the outstanding academic group and profound expertise, Creative Biolabs has successfully established the proprietary Sensitive Immunogenicity Assessment Technology® (SIAT®) system that can be utilized to evaluate the immunogenicity potential for a broad range of biotherapeutic drug candidates.

Biotherapeutic drugs, including protein, enzyme, antibody, antibody-drug conjugate (ADC), are of significant value in the treatment of various diseases. Compared to small molecule drugs, the advantages of biotherapeutic drugs are mainly manifested by prolonged half-life, high target specificity, and low intrinsic toxicity. However, the use of biotherapeutic drugs can lead to unwanted immune responses such as generation of anti-drug antibody (ADA) in patients, depending on multiple patient-related and product-related factors. The immune responses to biotherapeutic drugs decrease the efficacy of the drugs due to faster clearance of the drugs as antigens. In addition, unwanted immune system activation raises concerns of patient safety for issues such as rapid and enormous cytokine release. Therefore, immunogenicity risk management of biotherapeutic drugs and biosimilar biologics is critical for successful development. On the other hand, due to the enormous investment and cost in the whole process of developing a biotherapeutic drug candidate, it is worthwhile and necessary to assess the immunogenicity at the early stage of the drug discovery process. Above all, immunogenicity assessment is one of the major requirements for IND application.

Example roadmap for immunogenicity prediction.
(Jawa et al. 2013)

Creative Biolabs is one of the leading service providers for biotherapeutic drug development. Our scientists have gained extensive experience through years of cooperation with customers across the world. Our comprehensive SIAT® system offers in silico, in vitro, ex vivo, in vivo immunogenicity assessment and ADA assay services. We also provide de-immunization service if high immunogenicity potential is identified. All these services will assist customers in candidate selection and optimization in different phases of new biotherapeutic drug development.

SIAT <sup>®</sup> Immunogenicity System

Featured Services of SIAT® System

In Silico Immunogenicity Assessment
SIAT® in silico immunogenicity assessment is able to analyze and predict the potential immunogenicity of biotherapeutic drug candidates. The protein sequences are analyzed by modern bioinformatics combined with experimental human HLA binding data to estimate the binding affinity of the peptide to HLA, which can predict the potential of the peptide for T cell activation. Our SIAT® in silico immunogenicity assessment service is best fit for early discovery and exploring stage. read more…

In Vitro Class II HLA Binding Assay
Although the in silico models can predict the binding affinity of peptides in biotherapeutic drug candidates to class II HLA alleles, the accuracy of these prediction algorithms is not always in accordance with physical binding data. Therefore, after having defined the epitopes of interest in silico, further in vitro assays are needed to validate these predictions, among which class II HLA/MHC binding assay is the most widely used. read more…

Ex vivo Immunogenicity Assessment
Creative Biolabs offers SIAT® ex vivo immunogenicity assessment service that utilizes human peripheral blood mononuclear cells (PBMCs) to provide an immune response model. This model closely resembles the immune response in vivo. The responses of T cells or B cells to candidate biotherapeutic drugs are evaluated. Multiple techniques such as ELISPOT, ELISA, and Flow Cytometry are used according to different needs. read more…

In vivo Immunogenicity Assessment
SIAT® in vivo immunogenicity assessment employs the standardized immunogenicity assessment protocols with a personalized approaching strategy. HLA transgenic mice or humanized mouse models are available at our facility and collaboration partners. These mouse models provide functional and reliable elements of human immune systems without putting patients at risk. read more…

Anti-drug Antibody (ADA) Assay
Anti-drug antibody (ADA) has been observed in many preclinical and clinical studies, resulting in significant impacts in efficacy, toxicology, and pharmacokinetics of biotherapeutic drugs. The detection and confirmation of ADAs, as well as neutralizing antibodies (NAbs), comprise a fundamental part of immunogenicity assessment. Following current FDA and EMEA guidelines and AAPS white papers, SIAT® system can detect ADAs by using a variety of leading instrumentation platforms, such as ELISA/RIA, surface plasmon resonance (SPR) and electrochemiluminescence (ECL). read more…

De-immunization Service
Various techniques have been developed to reduce the immunogenicity of biotherapeutic drugs while preserving their activity. However, some humanized antibodies are still immunogenic to some extent and even fully human antibodies, produced by phage display technique or transgenic mice, may show degrees of immunogenicity. Taking advantages of our SIAT® system, we can identify potential T cell epitopes and introduce specific mutations to remove these epitopes to get a less immunogenic candidate. read more…

Reference
Jawa, Vibha, et al. "T-cell dependent immunogenicity of protein therapeutics: preclinical assessment and mitigation." Clinical Immunology 149.3 (2013): 534-555.




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