Efficacy & Toxicity Studies

With a strong focus on immuno-oncology applications, we provide translational in vivo efficacy studies, PK/PD, toxicity, and in vitro assays.

Translational Efficacy & Toxicity 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 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.

Services We Offer

Using these models, our in vivo pharmacology services include in vivo efficacy, pharmacokinetics (PK), pharmacodynamics (PD) and biomarker assessments, and pathology and toxicology studies.

We assess the efficacy of 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, antibody-dependent cellular cytotoxicity (ADCC), complement-dependent cytotoxicity (CDC), target binding, receptor occupancy (RO), cell proliferation and cell death, and cell reporter assays. 

Why Biocytogen?

We have successfully supported our pharmaceutical and biotech customers in evaluating the efficacy of multiple biologics (including monoclonal antibodies, bispecific antibodies, and recombinant proteins), peptides, small molecules, CAR-T cell therapy, and oncolytic viruses.  Our Preclinical Services Division completes over 800 drug evaluation projects yearly. 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 Services Division will continue to deliver high-quality, timely and cost-effective services, provide comprehensive and accurate data, and facilitate drug discovery and development for our customers worldwide.

 

Read on for more details and case studies:

In vivo Efficacy

PK & PD Studies

Efficacy & Toxicity Case Studies

Inflammatory Disease Modeling

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