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BioDuro LLC

Table of Contents

BioDuro LLC is an end-to-end contract research, development, and manufacturing organization (CRDMO) based in the United States and China that provides services to biotechnology and pharmaceutical companies.

In this article, we survey and summarize the features of the company's contract non-clinical testing services, examples of the pathological models it possesses, and case studies of non-clinical testing.

Features of BioDuro LLC's Contract Non-clinical Trial Services

Accelerate drug discovery through one-stop operations

BioDuro LLC offers a wide range of services to its partners, from target identification to API development to commercial drug manufacturing. Rather than simply providing individual studies, the services are offered as an integrated service that addresses the full affirmation of a project, from the early stages of drug discovery to the stage at which an IND application can be filed. This one-stop operation allows clients to significantly accelerate drug discovery.

Strengths in the fields of oncology, inflammation and respiratory

In the area of non-clinical testing services, we have strengths in the fields of oncology, inflammation, and respiratory medicine. For example, in the area of oncology, we provide services to support drug discovery for anticancer drugs using 2D and 3D cellular models and xenograft mouse tumor models. In this area, we have an experienced team of scientists with in-depth knowledge of cancer biology and an AAALAC-accredited breeding facility.

Provides DMPK services

Based on its position as a global CRDMO supporting the discovery, development, and commercial production of new drugs, the company offers DMPK services. Characterized by the flexibility to be configured for each stage of drug development, clients can choose from a wide range of in vitro and body analysis studies. Data from the studies help clients gain a deeper understanding of the physiochemical and metabolic properties of each drug product.

Each of the company's team of experts has long industry experience, which allows them to carefully understand the client's unique challenges and recommend a DMPK assay that meets their drug development goals. We are also able to address R&D, formulation development, and manufacturing needs after DMPK studies have been completed.

3 Specialized Pre-clinical CROs for Advanced Drug Discovery

An example of pathological model owned by BioDuro LLC

BioDuro LLC offers a variety of pathological models. For example, in the field of oncology, we have more than 500 cancer cell lines and 300 xenograft models (CDX), more than 90 patient-derived xenograft models (PDX), and many other diverse animal models.

Other specific disease models are also provided in the respiratory system, such as bleomycin-induced pulmonary fibrosis in mouse models and OVA-induced asthma mouse/rat models.

BioDuro LLC Non-clinical Trial Case Study

Support for IND application of DigmBio in Korea

The company is assisting BioDuro LLC in obtaining IND approval from the Korea Food and Drug Safety Agency (MFDS) for a drug developed by Korean biotechnology company DigmBio.

Reference: BioDuro official website (https://www.bioduro.com/news-resources/company-news/digmbio-announced-ind-clearance-from-korea-mfds-for-selective-parp1-inhibitor-dm5167.html)

BioDuro LLC Company Information

Headquartered in Irvine, California, BioDuro was founded in 1996 and has seven R&D and manufacturing sites in the United States and China.

Address	72 Fairbanks, Irvine, CA 92618, USA
Tel	+1 949 639 8100
Website	https://www.bioduro.com

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.

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.

Consult study design and disease model development
with SMC Laboratories, Inc.

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Safety Studies
Comprehensive Safety Evaluation for FIH Applications

Labcorp Holdings Inc.
(Labcorp Drug Development)

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.

Consult Labcorp Holdings Inc.
Discuss GLP/ICH-compliant study design for your FIH submission.

To labcorp.
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Pharmacokinetic (PK/PD) Studies
High-Precision Bioanalysis for Clinically Predictive PK/PD Evaluation

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.

Consult Phoenix Bio for PK/PD analysis with a clinical focus

Phoenix Bio.
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