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Crown Bioscience, Inc.

Table of Contents
Table of Contents

Crown Bioscience, Inc. is a contract research organization (CRO) specializing in non-clinical studies, with proprietary disease models and in-house research facilities. The company supports drug discovery across multiple therapeutic areas, including immuno oncology and metabolic diseases, providing comprehensive research solutions. Crown Bioscience, Inc. operates globally, with facilities across Asia, Europe, and the United States

Features of Crown Bioscience, Inc.’s Non-Clinical Study Services

Advanced Immunosafety Assessment Using Humanized Mouse Models

Crown Bioscience, Inc. utilizes humanized mouse models, such as HuGEMM™ and HuCELL™, in which human targets are knock-in, to conduct in vivo evaluation of complex on-target and off-target toxicities (irAEs) induced by immunotherapeutics including immune checkpoint inhibitors, bispecific antibodies, and ADCs. Efficacy and toxicity can be measured simultaneously within the same animal species, allowing accurate determination of the therapeutic index and ensuring rapid, reliable data delivery.

Precise Physiological Function Evaluation Using Continuous Monitoring Technology

In safety pharmacology studies using rodents, continuous and long-term monitoring of blood pressure, heart rate, and blood glucose is conducted through radiotelemetry and DSI telemetry systems.

This enables accurate capture of fluctuations in cardiovascular, metabolic, and renal functions, providing a comprehensive understanding of compound-related adverse effects.

Long-term follow-up studies such as four week study is also available, enhancing the reliability of the overall safety profile.

Integrated Pharmacokinetic Analysis Through DMPK Services Across Multiple Species and Dosing Routes

At Crown Bioscience, in vivo pharmacokinetic (PK) evaluation is also available for both small- and large-molecule drugs. They support multiple administration routes including intravenous, oral, intraperitoneal, subcutaneous, and intramuscular dosing.

Studies can be performed in a variety of species—mouse, rat, rabbit, dog, NHP, pig, and human. PK profiles include single, repeated, and cassette dosing, as well as MTD studies and tissue distribution/excretion analysis.

They deliver high-quality data consistently under robust quality assurance framework.

Example of Disease Models Provided by Crown Bioscience, Inc.

Cancer Models that Can Reproduce Human Immune System Using the MiXeno™ Platform

The MiXeno™ platform is a unique in vivo model that combines PBMC (human peripheral blood mononuclear cells) with cell line-derived xenograft (CDX) models, enabling partial reconstitution of the human immune system.

This allows evaluation of immune responses within the human tumor microenvironment. By reconstructing limited T-cell populations, this model allows rapid and cost-effective assessment of drug efficacy for multiple cancer types, including breast, colorectal, lung, lymphoma, and melanoma.

Reference URL:.
https://crownbio.jp/model-systems/in-vivo/mixeno

Case Study

Orthotopic Models Using High-Frequency Ultrasound Imaging

Crown Bioscience, Inc. has established orthotopic (in situ transplantation) tumor models using high-frequency (HF) ultrasound technology, enabling accurate tumor implantation and real-time tracking in organs such as the liver and pancreas. Combined with non-invasive, high-resolution 2D and 3D imaging, this approach reduces animal burden, increases throughput, and allows rapid and reproducible tumor growth evaluation.

Reference:
https://www.crownbio.com/model-systems/in-vivo/orthotopic-models-with-ultrasound-imaging

Company Information

Address2-11-8 Shiba Daimon, Minato-ku, Tokyo, Japan
Tel03-4363-1361
Websitehttps://crownbio.jp/
3 Recommended Contract Research Organizations for Non-Clinical Studies
— by Target goal and Expertise

In drug discovery, the quality and efficiency of non-clinical studies have a direct impact on clinical success rates, development costs, and overall length of time required in R&D. In recent years, there has been more demand for clinically relevant data, globally accepted reliability, and accurate early-stage screening. Thus, it is more important than ever to select the right CRO (Contract Research Organization) for strategic approach.
In this article, we highlight three CROs with proven technical capabilities, expertise, and long standing track records. These are our TOP 3 choices based on their capabilities and the specific target goals of the researchers for their non-clinical studies.

Pharmacology (Efficacy) Studies
Replicate unknown pathological models and
Discovery to clinically oriented drug evaluation
SMC Laboratories, Inc.
SMC Laboratories, Inc.
Reference: SMC Laboratories, Inc. official website (https://www.smccro-lab.com/jp/)
  • SMC Laboratories, Inc. has established a disease models using patented mouse technologies. The company has established proprietary pathological models—particularly in liver disease and fibrosis—and continues to expand their approach across a wide range of models in cancer, inflammation, and metabolic diseases.
  • From exploratory research to clinically oriented efficacy evaluation, SMC offers customized study designs, dosing strategies, and evaluation analysis tailored to each project. Their collaborative approachallows researchers to discuss and refine study plans together with SMC’s expert scientists.

  • With flexible small-scale study options and strong technical support, SMC Laboratories, Inc. is an ideal partner for start-ups, biotech ventures, and academic institutions alike.
Safety Studies
Comprehensive Safety Evaluation for FIH Applications
Labcorp Holdings Inc.
(Labcorp Drug Development)
Labcorp Holdings Inc.
Reference: Labcorp Holdings Inc. official website (https://jp.labcorp.com/)
  • Labcorp Holdings Inc. provides a fully integrated GLP testing system aligned with international regulatory standards, including FDA, EMA, and PMDA requirements. All studies are conducted under ICH-compliant quality assurance, making it ready for data submission.
  • The company has extensive expertise in long-term toxicity studies such as Segment I–III reproductive and carcinogenicity studies, as well as 2-year chronic toxicity assessments.
  • Labcorp Holdings Inc.’s comprehensive approach enables sponsors to efficiently outsource the entire preclinical package from toxicology, toxicokinetic (TK), and safety pharmacology study design to execution. This accelerates a path to First-in-Human (FIH) trials. For most of the global drug developers, this all-in-one service structure minimizes cost, risk, and expedite the time before advancing to clinical phase.
Pharmacokinetic (PK/PD) Studies
High-Precision Bioanalysis for Clinically Predictive PK/PD Evaluation
PhoenixBio Co., Ltd.
PhoenixBio Co., Ltd.
Source: PhoenixBio Co., Ltd. Official Website (https://phoenixbio.co.jp/)
  • PhoenixBio Co., Ltd.offers pharmacokinetic and hepatic metabolism studies using their proprietary PXB-mouse®, a humanized-liver chimeric mouse model. This platform enables the acquisition of data with high clinical correlation in ADME, drug–to-drug interaction studies, bridging the gap between preclinical and clinical stages.
  • With advanced LC-MS/MS-based bioanalysis, PhoenixBio Co., Ltd. provides aseamless workflow from plasma concentration measurement and metabolite identification to quantitative validation.

  • The company offersan integrated evaluation analysiscovering pharmacokinetics, hepatotoxicity, and safety with flexibility to accommodate complex modalities such as oligonucleotide and middle-molecule therapeutics. For compounds where hepatic metabolism is a development bottleneck—or where quantitative, reproducible exposure data are critical—PhoenixBio Co., Ltd. delivers unmatched analytical precision and consistency.

By region
list of animal models
Expertise & Track Record
3 Recommended Contract Non-Clinical Testing Services