Creative BioLabs has developed Sensitive Immunogenicity Assessment Technology® (SIAT) to assay immunogenicity in accordance with specific FDA and EMA guidelines. As a highly sensitive and unique assessment, SIAT includes in vivo, ex vivo, in vitro and in silico methods, which are effective in a wide range of applications including quantitation of biological drugs, determination of anti-drug antibodies (ADAs) and measurement of pharmacokinetic/pharmacodynamic markers.
From： American Association of Pharmaceutical Scientists Journal, 14: 296-302, 2012
SIAT In vivo offers unique test methods using rodents to investigate the immunogenicity of therapeutic antibodies, peptides, and proteins. Local lymph node, hypersensitivity response measurement and cutaneous anaphylaxis are involved to detect. SIAT Ex vivo is an accurate and sensitive method to address the potential immunogenicity of drug candidates ex vivo. Creative BioLabs offers ex vivo immunogenicity assessment in both rodents and humans by measuring CD4+T cells and dendritic cells (DC) responding to biological candidates. SIAT In vivo is carried out to extensively test the biocompatibility of therapeutic antibodies, peptides, and proteins and other customer's products. Creative Biolabs addresses immunogenicity with a broad coverage of the human species all over the world. Stable blood supply, strict quality control and multi-parameter measurement guarantee the assay consistency and traceability of each sample.
SIAT In silico offers high throughput screening of sequences of candidate molecules (therapeutic proteins) for possible risk of immunogenicity based on the T cell epitope content. Pharmaceuticals and Biotechnology companies can use Creative Biolabs SIAT at all stages of therapeutic protein, including Immunogenicity Monitoring, Biotherapeutic Safety and Efficacy Assays. Therapeutic proteins, antibodies and recombinant proteins often cause development of ADAs. These ADAs lead to reduced efficacy through rapid clearance or neutralisation of the drug by the immune system of the patients. Creative Biolabs SIAT attaches importance to drug safety and efficacy, and provides an understanding of the immunogenicity of biological drug molecules.