Nonclinical Efficacy Testing » Non-Clinical CROs and Agencies » Cyagen

Cyagen

Cyagen is a contract research organization (CRO) providing non-clinical research services in drug discovery and regenerative medicine. The company delivers highly reproducible data through integrated services ranging from custom mouse model generation to in vitro and in vivo evaluations.
As Cyagen primarily operates as a research institution conducting studies in-house, it does not function as an intermediary agency.

Features of Cyagen’s Contract Services for Non-Clinical Studies

Integrated In Vivo and In Vitro Platforms for Comprehensive Efficacy Evaluation

Cyagen supports both in vivo efficacy studies using immunodeficient and humanized mouse models and in vitro evaluations utilizing cell-based assay systems.
The company leverages proprietary NKG mouse models alongside extensive oncology and immune reconstitution models to precisely evaluate the therapeutic efficacy of cell-based therapies, including CAR-T and NK cell therapies.
Multifaceted endpoints—including cytotoxic activity, cytokine secretion, ADCC, and ADCP—support the generation of highly reproducible preclinical datasets.

One-Stop Platform for Rapid Delivery of High-Quality Mouse Model

Cyagen provides customized genetically engineered mouse models—including knockout, knock-in, and transgenic lines—within accelerated timelines.
Using proprietary technologies such as TurboKnockout® and CRISPR-Pro, founder mice can be generated in as little as three to six months.
Cyagen maintains a fully integrated workflow covering genetic engineering, breeding, and quality validation, enabling cost-effective model development that accelerates drug discovery programs.

AI-Integrated Gene Therapy Development Platform

Cyagen offers CRO services integrating artificial intelligence with experimental validation for gene therapy development.
By leveraging its Rare Disease Data Center (RDDC) and deep learning technologies, Cyagen supports workflows from pathogenic mutation identification to AAV vector design and in vivo validation.
The combination of AI-driven predictive analysis and validation using custom cell and animal models streamlines early discovery through preclinical development, contributing to accelerated R&D timelines and improved success rates.

Example of Disease Models Available at Cyagen

Custom Mouse Models for Human Disease Research

Cyagen maintains a broad portfolio of genetically engineered mouse models supporting drug discovery and disease research.
The company develops knockout, knock-in, and humanized mouse models using proprietary technologies, including TurboKnockout® and CRISPR-Pro, enabling rapid and highly accurate disease model generation.

Transgenic Mouse Models Using Gene Transfer Technologies

Transgenic mouse models replicate specific disease phenotypes or biological functions through random integration of exogenous genes.
Cyagen provides end-to-end services, including vector design, pronuclear microinjection, and screening, to establish multiple founder lines with varying expression profiles, allowing selection based on specific research objectives.

Cyagen Non-Clinical Case Studies

Integrated Efficacy Evaluation from Cell-Based Assays to Animal Models

Cyagen evaluates therapeutic efficacy of cell therapy candidates—including CAR-T and CAR-NK therapies—through both in vitro and in vivo platforms. In cell-based assays, immune cell activation is assessed through cytotoxicity assays against target cells and quantification of IFN-γ secretion.
In tumor xenograft studies using C-NKG mouse models, treated groups demonstrated tumor growth inhibition and prolonged survival.
These integrated experimental platforms support confirmation of therapeutic reproducibility and safety at the preclinical stage.

Saiyajen case study images
Reference: Cyagen's official website (https://www.cyagen.jp/business/products/cell-therapy-solutions/in-vitro-evaluation.html)
Saiyajen case study images
Reference: Cyagen's official website (https://www.cyagen.jp/business/products/cell-therapy-solutions/in-vitro-evaluation.html)
Saiyajen case study images
Reference: Cyagen's official website (https://www.cyagen.jp/business/products/cell-therapy-solutions/in-vivo-evaluation.html)
Saiyajen case study images
Reference: Cyagen's official website (https://www.cyagen.jp/business/products/cell-therapy-solutions/in-vivo-evaluation.html)

Cyagen Company Information

Address 2255 Martin Avenue, Suite E, Santa Clara, CA 95050-2709, USA
Tel +1 408-969-0306
Website https://www.cyagen.jp/

3 Recommended Contract Research Organizations
for Non-Clinical Studies
— by Target goal and Expertise

In non-clinical development, the choice of contract research organization shapes the quality of the data and the time it takes to reach the next decision. Below, three CROs are introduced by the type of study they support: pharmacology (efficacy) studies, safety studies, and pharmacokinetic (PK/PD) studies. Each summary describes the services the company offers so that you can match a provider to your target and development objective.

Pharmacology (Efficacy) StudiesDisease-Relevant Models for
Translational Drug Evaluation
SMC Laboratories, Inc.
Reference: SMC Laboratories, Inc. official website (https://www.smccro-lab.com/)

SMC Laboratories, Inc.

SMC Laboratories is a specialized non-clinical CRO focused on in vivo pharmacology and efficacy studies using disease-relevant animal models, particularly in fibrosis, inflammation, metabolic diseases, and oncology.

Areas of Expertise
Disease-Relevant Model Portfolio

SMC Laboratories offers models covering the liver, lung, kidney, intestine, and oncology. Its portfolio includes the proprietary STAM™ model for MASH, fibrosis, and hepatocellular carcinoma.

Study Design Based on Target Biology

Study plans are developed around the target biology, mechanism of action, disease stage, and development objective. Pharmacological endpoints can be combined with histopathology, biomarkers, and disease-specific readouts.

Support from Target Validation to Proof of Concept

With experience from more than 1,000 studies for clients in 30 countries, SMC Laboratories supports programs from target validation and candidate selection through in vivo proof-of-concept studies.

Safety StudiesComprehensive Safety Assessment for
Preclinical Development
Charles River Laboratories
Reference: Charles River Laboratories official website (https://www.criver.com/)

Charles River Laboratories

Charles River provides non-clinical toxicology and safety assessment services for programs ranging from exploratory safety studies to IND-enabling development.

Areas of Expertise
General Toxicology Across Study Designs

Services include single- and repeat-dose toxicology, dose-range finding, and general toxicology studies across multiple species and administration routes.

Non-GLP and GLP Study Support

Charles River supports both non-GLP and GLP studies, allowing sponsors to progress from early safety characterization to studies intended for regulatory submissions.

Integrated IND-Enabling Safety Assessment

Toxicology studies can be integrated with toxicokinetics, clinical pathology, histopathology, and safety pharmacology to support interpretation and IND-enabling safety packages.

Pharmacokinetic (PK/PD) StudiesConnecting Drug Exposure with
Pharmacological Response
Inotiv
Reference: Inotiv official website (https://www.inotiv.com/)

Inotiv

Inotiv provides integrated PK/PD, DMPK, and bioanalytical services to characterize drug exposure and its relationship with pharmacological response.

Areas of Expertise
Pharmacokinetic Characterization

PK studies characterize exposure, half-life, clearance, and other pharmacokinetic parameters needed to understand how a candidate behaves in the selected model.

Exposure–Response Evaluation

Pharmacokinetic data can be combined with pharmacodynamic endpoints and bioanalysis to evaluate the relationship between drug exposure and pharmacological response.

Integrated DMPK and Development Support

Integrated DMPK, pharmacology, and safety information supports candidate comparison, dose selection, dosing-frequency optimization, and decisions about subsequent preclinical development.

By Therapeutic Area
Disease Animal Models
and Reviews
Proven Capability, Expertise and Track Record
Top 3 Non-Clinical CRO Services