Preclinical Pharmacology Services

In vivo, In vitro, Ex vivo

Comprehensive Safety Profiling for IND Filing and Beyond

Understanding how a candidate behaves before first-in-human dosing drives smarter go/no-go decisions and optimizes dose selection. Medicilon's pharmacology service platform delivers a comprehensive, translational pharmacological continuum that bridges scientific innovation with regulatory readiness. As part of our preclinical pharmacology services, we integrate in vivo, in vitro, and ex vivo studies to generate robust, decision-ready data that support IND-enabling programs. From in vivo efficacy models, in vitro mechanistic assays, and ex vivo biomarker and tissue analysis, we provide robust data needed for confident IND-enabling decisions and successful clinical translation.

In vivo Pharmacology Studies

Our broad portfolio of in vivo oncology models enables the evaluation of drug efficacy, immune modulation, and mechanism of action across a range of therapeutic modalities. This foundation within our preclinical pharmacology services platform supports rapid proof-of-concept and dose-optimization decisions. 

Cell line-derived xenografts (CDX) are tumor models made by implanting human cancer cell lines into mice to study tumor growth and drug response

Patient-derived xenografts (PDX) are tumor models created by implanting human patient tumor tissues into mice to study cancer biology and treatment response

Orthotopic and systemic models involve implanting tumor cells into their original organ site or introducing them systemically to mimic natural tumor growth and metastasis

Syngeneic models use mouse tumor cells implanted into genetically identical mice to study tumor–immune system interactions in an intact immune environment

Humanized mouse models are mice engineered with human immune cells or tissues to study human-specific immune responses and immunotherapy effects in vivo

Inflammation and immune disease models replicate human immune or inflammatory conditions in animals to study disease mechanisms and evaluate therapeutic interventions

CNS pharmacology models simulate neurological and psychiatric disorders to study brain function, drug effects, and therapeutic mechanisms targeting the central nervous system

Cardiovascular and metabolic disease models mimic human heart and metabolic disorders to study disease mechanisms and evaluate potential therapies

Digestive system disease models replicate gastrointestinal disorders to investigate disease mechanisms and assess potential treatments for digestive health

Ocular disease models simulate eye disorders to study disease progression and evaluate therapeutic strategies for vision and ocular health

Case Studies

Proven Results with Medicilon

Small molecule efficacy in glioblastoma orthotopic models
Checkpoint antibody activity in colon cancer
T cell engager effects in systemic/solid tumors
CAR-T therapy in myeloma xenografts

Explore our preclinical oncology models and accelerate your therapeutic pipeline

In Vitro Assays

Our in vitro pharmacology services provide critical data on drug potency, mechanism of action, and stability in a controlled laboratory setting. These assays form an essential component of our broader pharmacology discovery services, supporting screening, profiling, and optimization of therapeutic candidates.

Applications Include:

Understanding the pharmacokinetics of a drug candidate is pivotal at every stage
Drug screening and profiling

Profile discovery to lead candidates for optimal physicochemical properties and target engagement.

Mechanistic investigations

Refine dosing strategies and predict human responses.

In Vitro ADME Assays

Drug screening and profiling

Our in vitro assays prioritize early-stage efficiency, enabling:

ADC catabolism studies in plasma, lysosome, and liver S9 fractions
Resistant tumor model analysis

Case study

NCI-H1975 osimertinib-resistant NSCLC model

In Vitro Drug Screening

 

  • Model: NCI-H1975 NSCLC parental vs. resistant cells
  • Assay: CCK-8, 3-day viability assay
  • Findings:
    • IC₅₀ value shifted from 65.9 nM (parental) to 10.94 µM (resistant)
    • Resistance Fold (RF): 166
In Vivo Efficacy Study
  • Animal Model: Balb/c nude mice (female)
  • Cell Implantation: NCI-H1975 parental and resistant cells, 2 × 10⁶ cells/mouse, right flank
  • Treatment Regimen: Osimertinib, 5 mg/kg, oral, QD × 21
Results:
  • Parental tumors showed strong sensitivity with 93.72% TGI at Day 20 and %T/C = 6.22
  • Resistant tumors exhibited reduced sensitivity with 70.05% TGI at Day 21 and %T/C = 28.11
In Vitro ADME Assays

Mechanistic investigations

Our in vitro assays prioritize early-stage efficiency, enabling:

Cathepsin-mediated payload release
ADC plasma stability evaluation

Case study

Cathepsin-medicated release

These in vitro pharmacology services support lead optimization, toxicity assessment, and mechanistic validation during candidate selection, empowering our clients to make data-driven development decisions.

Gain the insight you need - refine your development strategy today

Ex vivo Analysis

Ex vivo platforms extend the depth of pharmacological evaluation, bridging in vivo efficacy with molecular understanding of Medicilon’s preclinical pharmacology services.

Biomarker Analysis from Ex Vivo Samples
  • Molecular profiling of tissues, blood, plasma, and serum to quantify PD endpoints
  • Verification of drug – target engagement and pathway modulation through biomarker correlation
Tissue Distribution and Organ Profiling
  • Radiolabeled compound imaging and tissue quantitation post-mortem
  • Supports PK/PD modeling and organ-specific penetration (e.g., brain, liver, tumors)
Functional and Mechanistic Assays
  • Metabolic pathway and toxicity assessments using tissue biopsies
  • Ultrasound-guided and perfusion-based sampling for precision pharmacokinetics

Case Studies:

  • ADC biomarker analysis and tumor response evaluation
  • Combination therapy and radiation impact in glioblastoma models
  • ADC metabolism and plasma stability assessments

ADC plasma stability was assessed in mouse and human plasma over 21 days at 37°C, with small molecule payload shedding monitored by LC-MS/MS to evaluate metabolic stability across species.

Preclinical Strengths- WHY MEDICILON

Built for precision, backed by expertise

Custom Solutions

Tailored studies to match your project’s unique needs

Expert Teams

Over 20 years of experience delivering reliable data

Global Presence

State-of-the-art facilities in China and the US

Regulatory Compliance

IND/NDA-ready packages aligned with global standards

Enhance you IND package with ex vivo precision

Frequently Asked Questions

Pharmacology FAQs

Have more questions? Reach out to our experts.

Medicilon offers one of the industry’s largest portfolios, including more than 390 tumor models (xenograft, PDX, orthotopic, syngeneic, and humanized), over 240 non-tumor disease models, and specialized systems for CAR-T, immuno-oncology, transgenic, and drug-resistant tumors. Multiple species and custom model development services are also available.

In vitro solutions include high-throughput screening with tumor and resistant cell lines, proliferation and cytotoxicity assays, receptor occupancy studies, cytokine multiplex testing, ELISA/MSD platforms, and extensive immune function assessments such as ADCC/ADCP and cell differentiation. These assays play a vital role in lead optimization and mechanistic research.

Ex vivo analysis bridges in vivo and in vitro data by enabling molecular and functional studies on samples collected from animal models. Core approaches include biomarker quantification from blood/tissue, flow cytometry for immune phenotyping, post-mortem organ/tumor profiling for drug distribution (including radiolabeled compounds), and mechanistic assays such as metabolic profiling or advanced imaging of biopsied tissues.

Yes. Examples include:

  • ADC efficacy in colon tumor models, combining IVIS in vivo imaging with ex vivo biomarker analysis (Ki67, caspase-3).
  • Humanized mouse models, featuring ex vivo flow cytometry and cytokine profiling from PBMCs, tumors, and organs.
  • Orthotopic glioblastoma studies, pairing live in vivo imaging with detailed endpoint ex vivo tissue and molecular analyses.

This integrated approach produces robust, translatable data on efficacy, mechanism, safety, and immune effects in clinically relevant settings. By leveraging advanced models, analytical platforms, and cutting-edge assays, Medicilon reduces program risk, accelerates IND-enabling decisions, and improves clinical trial readiness.

Medicilon’s studies are powered by advanced instrumentation, including BD FACSymphony and LSRFortessa flow cytometers, IVIS Lumina/Spectrum imaging, small animal irradiation systems, and specialized surgical/biopsy tools, enabling multi-layered pharmacology studies and comprehensive ex vivo analyses.

Your Partner in Preclincal Pharmacology Research

With advanced modeling systems, imaging technologies, and biomarker platforms, Medicilon delivers preclinical pharmacology services designed to meet evolving regulatory and scientific expectations. Every study is supported by scientific rigor, operational efficiency, and a commitment to data integrity.

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