Creative Biolabs is supported by an advisory board with seasoned professionals in animal modeling, immunology, preclinical research and drug toxicology, analytical chemistry and immunologic analysis. We have accumulated extensive experience from the accomplishment of different projects, during which we have received a lot of recognition and praise from our clients.
Previous studies have demonstrated that the immunogenicity of therapeutic proteins can affect the efficacy of relevant antibodies, leading to high-cost production and serious adverse effects in clinical use. In recent studies, many attempts have been made to assess the immunogenicity of potential drugs during the early phase of discovery. A wide variety of assays have been developed for analyzing the safety of candidate drugs and reducing the production of side effects. Among them, in silico, in vitro, and in vivo models are commonly used to predict the immunogenicity, to reveal immunogenic properties, as well as to decrease the immunogenicity. For instance, in silico models have been generated based on predicting the binding of peptides to MHC molecules. In vitro models are designed to predict the neoepitopes, CD4+ T cell epitopes and the effect on T or B cell activation. Meanwhile, a number of scientists are pioneering studies of “de-immunization methods” to reduce the immunogenicity of therapeutic proteins in animal models. HLA transgenic mouse models have been considered as a perfect model to evaluate the effect of epitope modification on the blocking of HLA binding.
Fig.1 SIAT® Immunogenicity Assay for Preclinical Study.
Immunogenicity can be a major issue in the development of successful protein drugs. Pilot studies suggest that anti-drug antibodies (ADAs) caused by immunogenicity may influence the therapeutic function and lead to side effects in patients. As a result, immunogenicity assessment during preclinical development is critical to developing therapeutic proteins with high safety. Creative Biolabs provides a wide collection of SIAT® immunogenicity assays to predict the immunogenicity of therapeutic candidate drugs, including but not limited to:
Currently, we have developed a novel immune modeling platform to analyze the immune response that is related to a drug, a therapeutic protein or a potential antibody. To view the immunogenicity from the view of T cells, we have developed several models, such as in vivo and/or in vitro models to test immune responses in different kinds of animal models. For instance, in vitro T cell assays allows the analysis of T cell epitopes and their roles in the T cell activation. In addition, transgenic mice that express human proteins have been developed to assess relative immunogenicity of recombinant proteins or monoclonal antibodies (mAbs). Recent studies conducted by our lab indicate that this platform can be also used to predict neo-epitopes when given modified human insulin or various tissue activators.
Tissue damage is a significant factor that can lead to immune responses. The immune system is programmed to respond to distressed tissue that is associated with an altered protein expression followed by inflammation. Candidate drugs have been regarded as one of the main causes of tissue damage. In general, such damage can trigger immune responses against inflammation. In our SIAT® immunogenicity testing, the data of infiltration of lymphocytes are collected from different tissue sites, and it can be used to reveal the interaction between drug-induced tissue damage and immune response.
Creative Biolabs has an entrepreneurial team of highly-skilled and qualified experts in immunology, biochemistry and analytical chemistry. The members have originated from a rich academic research background, bringing their experience into translation. We are very proud of providing high-quality, omnidirectional immunogenicity assay services to our valued clients to remove the difficulties of your projects. If you are interested in our services, please contact us for more details.