Preclinical Toxicity & Efficacy Studies
Our Therapeutic Focus
Biocytogen’s Preclinical Services Division has established comprehensive in vivo and in vitro pharmacology capabilities and provides world-class services to our customers. Our team has significant expertise in testing novel therapeutics for immuno-oncology, oncology, and autoimmune/ inflammatory disease applications.
At the foundation of these in vivo preclinical efficacy studies are a large collection of genetically humanized mouse models for immune checkpoint inhibitors and cytokine/cytokine receptors, our highly immune-deficient B-NDG mice and their variants, including human immune reconstituted models using human PBMC and CD34+ engraftment, CDX (cell line-derived xenograft) models, and engineered cell line models.
Preclinical Services We Offer
Using these models, our in vivo pharmacology services include preclinical efficacy studies, pharmacokinetics (PK), pharmacodynamics (PD) and biomarker assessments, and pathology and toxicity studies.
We perform efficacy and toxicity studies for a wide range of biologics such as antibodies, vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins.
Complementary to our in vivo capabilities, our in vitro pharmacology services include immune cell profiling (e.g. tumor infiltrating lymphocytes (TIL) analysis), cytokine profiling, primary T, NK, and macrophage cell-based functional assays such as T cell activation, mixed-lymphocyte reaction (MLR), T cell cytotoxicity studies, antibody-dependent cellular cytotoxicity (ADCC), complement-dependent cytotoxicity (CDC), target binding, receptor occupancy (RO), cell proliferation and cell death, and cell reporter assays.
Cancer immunotherapy is one of the most promising anti-cancer therapeutic breakthroughs in recent years. Biocytogen specializes in immuno-oncology and preclinical oncology services, offering the highest quality and the most comprehensive collection of genetically humanized immune-checkpoint mouse models to accelerate the discovery and development of therapeutics. In addition, Biocytogen provides robust human immune cell-engrafted mouse models. Our CDX mouse models can be used to evaluate preclinical efficacy of novel immuno-oncology and oncology drugs.
We have successfully supported our pharmaceutical and biotech customers by providing preclinical efficacy studies and toxicity studies for multiple biologics (including monoclonal antibodies, bispecific antibodies, and recombinant proteins), peptides, small molecules, CAR-T cell therapy, and oncolytic viruses. Our Preclinical Services Division has completed drug evaluation projects for more than 200 partners worldwide. We have also successfully assisted our customers in IND applications. Supported by Biocytogen’s large-scale generation of new animal models and advanced gene editing technology, our Preclinical Pharmacology team will continue to deliver high-quality, timely and cost-effective efficacy studies and toxicity studies to facilitate drug discovery and development for our customers worldwide.
Read on for more details and case studies:
Efficacy & Toxicity Case Studies