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SIAT ® Immunogenicity System

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 the 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. Fig.1 Example roadmap for immunogenicity prediction. (Jawa et al., 2013)

Featured Services of SIAT® System

SIAT® Immunogenicity System. Fig.2 SIAT® Immunogenicity System.

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. Contact us to discuss your project and experience the great value of our services.

Reference

  1. Jawa, V.; et al. T-cell dependent immunogenicity of protein therapeutics: Preclinical assessment and mitigation. Clin Immunol. 2013, 149(3): 534-55.

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