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Translational Research Services
In Vitro/In Vivo/PK/PD/ADME/Tox/Efficacy
Compliance &
Accreditations
Last updated on 11th December 2025
Modern drug development demands more than discovery; it requires true translational research intelligence. Translational research is the decisive bridge between discovery and clinical success, where predictive preclinical models, mechanistic pharmacology, and biomarker-driven insights determine whether a therapeutic concept advances. As a specialized translational research CRO/CDMO, we provide scientifically rigorous, clinically aligned preclinical research services designed to reduce risk and improve translational outcomes. Outsourcing translational services to a flexible and innovation-driven partner offers critical advantages like scalable infrastructure, validated testing platforms, regulatory expertise, and faster decision-making.
We offer end-to-end translational support, from early discovery through IND-enabling studies, including:
- Clinically relevant preclinical models
- Mechanistic pharmacology and biomarker strategy
- PK/PD integration and translational modeling
- Preclinical toxicology (tolerability, efficacy)
- Predictive translational drug development approaches
Our mission is to reduce the high attrition rates common in preclinical development by integrating model fidelity, biological validation, and clinically aligned study designs. Through high-quality data packages, we help sponsors advance lead molecules with confidence and accelerate IND timelines.
CDX (Human Cell Line Xenograft)
Standard efficacy model. Subcutaneous or orthotopic implant of human tumor cell lines (e.g., MDA‑MB‑231, HCT116). Endpoints: TGI, survival, PK/PD, IHC
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Immuno-Oncology Studies
Mouse tumor lines in matched strains (e.g., 4T1, MC38, CT26, B16F10). Preserves intact immunity. Ideal for IO (CPIs, cytokines, siRNA/ASO combos)
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Humanized Immune Mouse model
CD34+ or PBMC‑reconstituted mice for human immune system interactions. Evaluate IO agents, T/NK cell engagers, oligo‑immune crosstalk
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PDX (Patient‑Derived Xenograft)
High translational relevance using patient tumor fragments. Maintains heterogeneity. Suitable for biomarker stratification and combo studies
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PK/PD Studies
Cmax, Tmax, AUC, t½, CL, Vd, bioavailability, accumulation, flip‑flop kinetics. Flow cytometry (IO panels), IHC/ISH, digital pathology, apoptosis/proliferation (CC3, Ki67)
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In vitro Studies
Cytotoxicity Assays, MoA Studies, Drug–Drug Interaction, Cellular Uptake & Distribution, Fluorescent imaging, IVIS, and subcellular localization studies., Biomarker Readouts, Metabolic Stability, High-Throughput Screening
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IND support
Comprehensive IND-enabling in vivo safety, PK/PD, and toxicology studies, compliant data capture, SEND conversion, and audit-ready reporting to support regulatory submissions
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Organoid & Spheroid Studies
Patient-derived and iPSC-derived 3D organoid cultures that recapitulate tissue architecture & heterogeneity, enabling high-fidelity efficacy and toxicity testing. Tumor spheroid assays provide scalable 3D systems for drug penetration, hypoxia, and viability profiling, bridging the gap between 2D in vitro assays and in vivo models
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Every breakthrough drug discovery depends on the ability to translate discovery into human relevance. True success in drug development demands translational precision, at NJ Bio, we go beyond standard CRO work. We build predictive models and assays grounded in human biology, delivering data that drives real clinical decisions not just reports.
Our Translational Research Services merge science, strategy, and insight to help you move forward with confidence, clarity, and a competitive edge. Our team forms the bridge between discovery and clinical success, where model reliability, biological validation, and data interpretation determine the fate of a promising compound.
Our services include a wide range of animal models and platforms, such as xenograft and patient-derived tumor models, immuno-oncology models, humanized mouse models, in vitro assays, and PK/PD studies. Each service is designed to deliver reliable, clinically relevant data that helps clients make faster and informed decisions for their drug development programs.
CDX (Human Cell Line Xenograft) studies
Xenograft mouse studies or xenotransplantation studies provide an effective platform for researching and evaluating novel clinical candidates. This approach involves transplanting cells or tissues from one species into a different host animal (usually immunodeficient) to study disease progression and treatment response. A cell-derived xenograft (CDX) is created by implanting well-characterized cancer cell lines into immunocompromised mice. These serve as exemplary translational research systems for investigating tumor biology and therapeutic efficacy. We offer access to over 200 authenticated human cancer cell lines. This extensive library provides diverse options for in vivo CDX CRO services and supports GLP / non-GLP xenograft testing of clinical candidates in vivo. Additionally, our custom CDX model development enables precise evaluation of compound performance in relevant tumor settings.
What we offer
Cell-line Derived Xenograft Models (CDX)
Access to >200 authenticated human cancer cell lines
Sourced from trusted repositories & validated in vivo
Low inter-animal variability
No off-target tumor growth
Custom orthotopic tumor model development
Novel or uncharacterized cell line modeling
Immuno-Oncology Studies
Our Immuno-Oncology (I/O) or syngeneic mouse tumor models provide a powerful approach for evaluating how cancer therapies perform in the presence of a functional immune system. These models enable immune oncology studies and support comprehensive immune oncology efficacy assessments by facilitating the investigation of immune-tumor interactions, the identification of novel immunotherapy targets, and the advancement of clinical candidates that stimulate anti-tumor immune responses. We offer – in vivo tumor models to investigate tumor-immune dynamics and immunophenotyping services such as luciferase tumor imaging, and immune profiling mouse tumors, with matched peripheral blood/tumor collections ideal for immune monitoring panels and tumor microenvironment analysis. Our platform also enables rigorous potency testing of drug candidates in cell-based and animal models by combining in vitro and in vivo assays. This comprehensive platform allows to evaluate immune responses, optimize therapeutic strategies and drive preclinical success.
Our portfolio of syngeneic mouse models is well characterized for their responses to clinically relevant immune checkpoint modulators, enabling immune checkpoint inhibitor studies with agents such as anti-CTLA-4, anti-PD-L1, and anti-PD-1. These models provide a reliable framework to test novel agents as monotherapies or in combination with standard-of-care treatments.
Validated syngeneic Models
| Cell Line | Mice Strain | Tissue Type |
| MC38/ MC-38 LUC/ MC38-hPD1/PDL1 | C57BL/6 | Colon |
| Panc-02 / Panc-02-LUC | C57BL/6 | Pancreas |
| LL/2 | C57BL/6 | Lung |
| 3LL | C57BL/6 | Lung |
| EG7.OVA | C57BL/6 | Lymphocyte |
| EMT-6 | BALB/C | Breast |
| 4T1 / 4T1 - LUC | BALB/C | Breast |
| ID8 | C57-Albino | Ovarian |
| ID8 - LUC | C57-Albino | Ovarian |
| Renca | BALB/C | Kidney |
| Renca-LUC | BALB/C | Kidney |
| M-109 (Madison-109) | BALB/C | Lung |
| CT26 | BALB/C | Colon |
| B16F10 | C57BL/6 | Melanoma |
| Raji-B | NSG-CD34+/Humanized | Lymphocyte |
| OVCAR-3 | NSG-CD34+/Humanized | Ovarian |
| TUBO | BALB/C | Breast |
| MMTV-PyMT TG (Spontaneous) | FVB/C57BL/6 | Breast |
| E0771 (CRL-3461) | C57BL/6 | Breast |
| KRAS-Mut/53/Pancreatic CRE | FVB/C57BL/6 | Pancreas |
| MB49 | C57BL/6 | Bladder |
What we offer
Immuno-oncology Platform
Fully validated tumor lines for reproducible and reliable in vivo studies
Comprehensive growth-curve datasets across multiple models, including therapeutic antibody response data (anti-CTLA-4, anti-PD-L1, and anti-PD-1)
Broad coverage of tumor types in I/O models, including colon, brain, lung, skin, liver, pancreas, kidney, and ovarian cancers.
Matched peripheral blood and tumor/spleen collections from our syngeneic models to maximize FACS analysis.
Humanized immune mouse models
Humanized immune mouse models enable the engraftment of human immune system components in immunodeficient mice, providing a platform to study human-specific drug responses and disease mechanisms. These models deliver clinically relevant insights for investigational therapeutics and serve as humanized mouse models to evaluate cancer immunotherapeutics.
Figure 2: Humanized mouse models for Immuno-oncology research
We offer humanized mouse models for immunotherapy that are engineered for robust engraftment of human hematopoietic stem cells (HSCs) and peripheral blood mononuclear cells (PBMCs). This allows for highly translational data to advance immunotherapies, infectious disease research, and hematologic disorder studies. Our experienced team will help you select the optimal humanization strategy for your program, design and execute tailored study plans and comprehensively profile immune responses, including cytokine profiling in humanized mice, to support translational decision-making. We also support CAR-T/TCR-T evaluation and precision oncology support through integrated immune and biomarker readouts as well as ADC efficacy services.
NJ Bio supports a wide range of drug discovery studies requiring humanized mice models including;
- Immuno-oncology drug testing
- CAR-T and TCR-T efficacy evaluation
- Hematopoietic stem cell research
- Infectious disease studies
- GvHD and immune-tolerance models
| Models | Benefits / Features |
| Hu-PBL-SCID | • Rapid engraftment of human CD3+ T cells using peripheral blood leukocytes • Ideal for short-term T-cell functional assays |
| Hu-SRC-SCID | • Full immune reconstitution via intravenous or intrafemoral delivery of CD34+ HSCs • Sources: bone marrow, cord blood, fetal liver, or G-CSF-mobilized peripheral blood |
| BLT (bone marrow–liver–thymus) | • Established by transplantation of human fetal liver and thymus under the kidney capsule and I.V. injection of autologous fetal liver HSCs • Supports comprehensive human immune development |
What we offer
Humanized Immune Mouse Models
CD34+ HSC Engraftment
Transplantation of human hematopoietic stem cells into immunodeficient mice to establish multilineage human immune systems
PBMC Engraftment
Rapid humanization using PBMCs, ideal for short-term immune response and graft-versus-host disease (GvHD) studies
Customized Cell Line Implantation
Support for co-engrafting tumor cells, CAR-T cells, or patient-derived cells for functional immune-oncology studies
Organ Specific Humanization
Custom engraftment protocols targeting specific tissues like spleen, liver or bone marrow
In vivo Immune Monitoring
Flow cytometry-based tracking of human immune cell subsets across tissues and time points
Patient-Derived Tumor Models (PDX)
Patient-derived xenograft (PDX) models are widely regarded as one of the most reliable tools for translational oncology research. They closely mirror the characteristics of human cancers, including tumor spatial structure, heterogeneity, genomic features and therapeutic response. This makes them highly predictive for preclinical evaluation of novel drugs,1 particularly for assessing tumor growth inhibition.
PDX mouse models are established by implanting tumor tissue or cells from a patient into immunodeficient mice, preserving the original tumor biology and providing clinically relevant insights into drug efficacy. We bring extensive expertise in PDX model studies to accelerate clinical translation and improve success rates. We support in vivo PDX efficacy models and provide comprehensive PDX response evaluation studies. Our library of over 1,000 fully validated PDX oncology models spans multiple disease indications, enabling the use of PDX tumor growth inhibition (TGI) models to measure therapeutic performance in clinically relevant settings. With our advanced platforms, we deliver precise analysis even in complex tumor microenvironments helping you generate accurate data for your lead candidates.
What we offer
Patient Derived Xenograft Models (PDX)
Library of >1000 PDX models across tumor types
Suitable for immunocompromised & humanized mice
Preserved tumor heterogeneity & molecular fidelity
In vitro Studies
NJ Bio’s advanced in vitro platform produces high-quality, useful data to accelerate drug discovery and development. Our capabilities support preclinical in vitro testing, enabling rapid screening and mechanism-of-action assessment. By integrating innovative techniques such as flow cytometry (FACS) and confocal microscopy with our deep expertise in immunology and oncology, we deliver accurate, high-resolution, and quantitative insights. Our in vitro cytotoxicity studies provide a reliable foundation for understanding complex biological mechanisms and evaluating drug candidates and this includes in vitro services for ADCs, which assess antibody-drug conjugates in cell-based assays to evaluate target binding, potency, and mechanism of action (MoA).
Figure 5: FACS (Flow cytometry) data
What we offer
In vitro studies
Confocal Microscopy
- High-resolution 3D imaging of cellular structures, subcellular localization and co-localization of markers
- Live-cell imaging, immunofluorescence and apoptosis detection
FACS (Flow cytometry)
- Multi-colour immunophenotyping & surface marker analysis
- Cell sorting, proliferation tracking, and immune cell profiling
- High-throughput analysis with customized antibody panels
In vitro Cell-Based Assays
- 2D & 3D tumor models, including patient-derived cultures
- Functional assays, cytotoxicity, apoptosis
- Real-time & end-point detection platforms
MoA & Target Validation
- Pathway activation & inhibition studies
- RNA, protein & signaling cascade analysis
- CRISPR, RNAi, phospho-protein & transcriptional profiling
In vitro imaging & assays
- High-content screening using confocal platforms
- Small molecule & biologic libraries
- Hit Identification & phenotypic screening
Biomarker Screening
- Predictive & pharmacodynamic biomarker assays
- FACS- and imaging-based biomarker qualification integrated with downstream in vivo models for translational alignment
In vivo PK/PD (Pharmacokinetic/ Pharmacodynamic) studies
In drug development, PK/PD studies form the scientific foundation for understanding how a drug behaves in the body and how it exerts its effects. Our experienced team provides in vivo pharmacology services to assess key parameters in support of IND-enabling studies.
In vivo PK (Pharmacokinetic) studies assess the absorption, distribution, metabolism, and excretion (ADME) of a drug. Our in vivo PK studies enable establishment of optimal dosing schedules, routes of administration, and ensuring drug levels are both effective and safe.
Pharmacodynamics (PD) studies investigate the biological and physiological effects of a drug, and its mechanism of action. These studies inform dose selection by linking drug exposure to efficacy and safety outcomes. In vivo services for ADCs involve evaluating antibody-drug conjugates in animal models to assess exposure, efficacy, and safety prior to clinical development. We support ADC in vivo services, dose response studies to determine exposure-effect relationships, and PK/PD analysis in PDX models to correlate drug levels with therapeutic outcomes in patient-derived tumors.
We also conduct in vivo toxicology and safety assessment, including dose-limiting toxicity evaluations, MTD studies, and tolerability profiling of biologics and small-molecules. Our studies incorporate histopathology endpoints to assess tissue-level effects, biodistribution imaging to track therapeutic localization, and payload release kinetics with emphasis on ADC linker release to understand mechanism-based delivery and off-target exposure. Our platform can support candidates such as ADCs, AOCs (Antibody-oligonucleotide conjugates), protein degraders, and medicinal chemistry leads, enabling comprehensive translation from discovery through preclinical development.
Find out more about our bioanalytical services by clicking here.
IND Enabling Research Services & Data Management
Our team specializes in providing IND-enabling services to support every stage of your Investigational New Drug (IND) application journey. Our team partners with you to compile and interpret critical preclinical data and prepare high-quality regulatory documents. We bring expertise in managing and analyzing data from preclinical safety and efficacy studies, ensuring a smooth transition to first-in-human trials. Our services include development of robust data systems compliant with GLP guidelines, ensuring the collection, analysis and reporting of high-quality data that demonstrates a drug’s potential safety and efficacy for regulatory submissions.
What we offer
IND-Enabling Research Services & Data Management
Data Integration & Interpretation
We compile and review your preclinical toxicology, pharmacology, and PK/PD data to make sure it supports the goals of your program and complies with FDA submission requirements
Regulatory Document Preparation
Our team prepares all necessary components of the IND application, including study reports, investigator brochures, pre-IND briefing documents, and CTD modules (2, 4, and 5)
Strategic IND Guidance
We offer professional advice on research design, find data gaps, and help you in organizing your IND strategy to reduce delays and meet regulatory requirements.
Agency Communication Support
We offer transparent, effective interaction with regulatory bodies, from preparing for pre-IND meetings to generating answers to agency inquiries
Organoid and Spheroid Studies
We provide advanced 3D cell culture models including organoid and spheroid studies, offering physiologically relevant systems for drug discovery, oncology research, and preclinical screening. In addition to 2D cell culture assays, our organoid and spheroid systems provide enhanced biological relevance and improved functional readouts. These models bridge the gap between traditional 2D cultures and in vivo models, enabling predictive, high-throughput solutions for early-stage drug evaluation. Our 3D culture platforms help reduce drug attrition, predict patient response and better capture the complexity of human disease. We further enhance these studies with advanced analytical techniques, including high-content imaging (HCI) for morphology and viability assessment, 3D spheroid tumor assays to evaluate therapeutic response in tumor-like structures, multiplex cytokine profiling using Luminex-based assays, flow cytometry for immune cell interactions, and histology with IHC for detailed tissue-level characterization of embedded spheroid and organoids.
Translational relevance of 3D Cell Models
Unlike 2D monolayer cultures, 3D organoid in vitro models and spheroids closely mimic in vivo tumor architecture, microenvironment, and cellular heterogeneity, leading to more reliable translational data. These models are ideal for evaluating:
- Anti-cancer efficacy and resistance mechanisms
- Immuno-oncology responses in co-culture with immune cells
- Cell-cell and cell-matrix interactions
- Personalized medicine approaches using patient-derived samples
Reference(s):
- Liu, Y., Wu, W., Cai, C., Zhang, H., Shen, H., & Han, Y. (2023). Patient-derived xenograft models in cancer therapy: technologies and applications. Signal Transduction and targeted therapy, 8(1), 160.
