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.
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.
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.
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.
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.
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.
| Address | 9F MetLife Shin-Yokohama Building, 3-8-11 Shin-Yokohama, Kohoku-ku, Yokohama-shi, Kanagawa-ken |
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| Tel | +81 (45)-475-3887 |
| Website | https://www.reprocell.com/ |
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.
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.
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 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.
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.
Charles River provides non-clinical toxicology and safety assessment services for programs ranging from exploratory safety studies to IND-enabling development.
Services include single- and repeat-dose toxicology, dose-range finding, and general toxicology studies across multiple species and administration routes.
Charles River supports both non-GLP and GLP studies, allowing sponsors to progress from early safety characterization to studies intended for regulatory submissions.
Toxicology studies can be integrated with toxicokinetics, clinical pathology, histopathology, and safety pharmacology to support interpretation and IND-enabling safety packages.
Inotiv provides integrated PK/PD, DMPK, and bioanalytical services to characterize drug exposure and its relationship with pharmacological response.
PK studies characterize exposure, half-life, clearance, and other pharmacokinetic parameters needed to understand how a candidate behaves in the selected model.
Pharmacokinetic data can be combined with pharmacodynamic endpoints and bioanalysis to evaluate the relationship between drug exposure and pharmacological response.
Integrated DMPK, pharmacology, and safety information supports candidate comparison, dose selection, dosing-frequency optimization, and decisions about subsequent preclinical development.