Nonclinical Efficacy Testing » Non-Clinical CROs and Agencies » Reprocell (Biopta)

Reprocell (Biopta)

Reprocell (Biopta) isA global CRO with strengths in non-clinical evaluation using fresh human tissuesIt is. In addition to contract testing for efficacy, safety, ADME, etc., we also support ex vivo evaluation using patient-derived tissues.

Features of Reprocell's (Biopta) non-clinical contract testing services

Evaluate candidate compounds using fresh human tissue

The major feature of Reprocell (Biopta) isTest systems utilizing fresh human tissues, including those of patient originIt enables ex vivo evaluation of drug efficacy and safety across a wide range of tissues, including IBD, skin diseases, respiratory, and cardiovascular systems. Because human responses, which are difficult to capture with animal models alone, can be confirmed from the early stages of drug discovery, it can be utilized for Go/No-Go decisions on candidate compounds and decisions on transitioning to clinical trials. We also have a track record of being involved in the evaluation of over 1,000 new drug candidates since 2002.

Human tissue testing compliant with GLP

The company offersCRO GLP-certified for testing using fresh human tissueIt also supports evaluations based on ICH S7A in safety pharmacology, which can be conducted as GLP studies when necessary. In addition, comparative studies across animal species are available, making it possible to examine to what extent data obtained in animals can be replicated in humans. Because human tissue is handled, an organizational framework for tissue procurement is in place, including ethical review and informed consent.

Efficacy and ADME evaluation utilizing human tissue

In ADME/DMPK,Evaluation of permeability and metabolism in human gastrointestinal tissue using the Ussing chamberIt supports applications such as these. A key feature is the ability to evaluate while maintaining the enzymes and transporters inherent to human tissue, which are difficult to reproduce in conventional cell lines or animal tissues. Furthermore, it supports drug efficacy evaluation using patient-derived tissues, iPSC-derived models, and 3D tissue models. It also accommodates GLP studies intended for submission to regulatory authorities.

Source: Reprocell official website
https://www.reprocell.com

An example of a disease model owned by Reprocell (Biopta)

At Reprocell (Biopta),inflammatory bowel diseases (IBD) such as ulcerative colitis and Crohn's diseaseWe offer human tissue models targeting . Using patient-derived intestinal tissue, we can evaluate the effects of candidate compounds on inflammatory responses and intestinal permeability. We also offer human tissue assays targeting diseases such as psoriasis, atopic dermatitis, COPD, and asthma.

Source: Reprocell official website
https://www.reprocell.com

Non-clinical study cases of Reprocell (Biopta)

Evaluate the safety of nNOS inhibitors in human resistance vessels

At Reprocell (Biopta),Vascular safety of selective nNOS inhibitorsThis has been investigated using fresh human subcutaneous resistance vessels. The presence or absence of human-specific vasoconstrictive risks and side effects, which are difficult to predict in animal models, is directly verified using human tissue. It is utilized as a method to reduce cardiovascular safety risks during the preclinical stage before proceeding to clinical trials.

Source: Reprocell official website Demonstrating Functional Vascular Safety of a Selective nNOS Inhibitor in Human Resistance Arteries
https://www.reprocell.com/demonstrating-functional-vascular-safety-of-a-selective-nnos-inhibitor-in-human-resistance-arteries

Corporate Information of Reprocell (Biopta)

Source: Reprocell official website
https://www.reprocell.com
Address9F MetLife Shin-Yokohama Building, 3-8-11 Shin-Yokohama, Kohoku-ku, Yokohama-shi, Kanagawa-ken
Tel+81 (45)-475-3887
Websitehttps://www.reprocell.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.
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 approach allows 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 a seamless workflow from plasma concentration measurement and metabolite identification to quantitative validation.
  • The company offers an integrated evaluation analysis covering 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 Therapeutic Area
Disease Animal Models
and Reviews
Proven Capability, Expertise and Track Record
Top 3 Non-Clinical CRO Services