Nanoparticle Cellular & In Vivo Evaluation

Nanoparticle Cellular & In Vivo Evaluation

Accelerating Nanomedicine from Concept to Preclinical Proof of Value

Nanoparticle-enabled therapeutics—including lipid nanoparticles (LNPs), polymeric nanocarriers, and inorganic nanosystems—are redefining drug delivery for mRNA therapeutics, siRNA, gene editing, biologics, and next-generation vaccines. To successfully advance these complex modalities toward the clinic, developers in pharmaceutical companies, biotech firms, and emerging RNA-therapy innovators require precise, reproducible, and regulatory-compliant evaluation across both cellular and in vivo models.

Our integrated Nanoparticle Cellular & In Vivo Evaluation Services deliver a comprehensive suite of preclinical capabilities that support each stage of nanoparticle R&D. From early formulation behavior, cellular uptake, and mechanistic assays, to in vivo biodistribution, PK/PD, and disease-model pharmacology, we provide end-to-end scientific insights that help you optimize delivery efficiency, validate therapeutic potential, and derisk development decisions. Whether your program involves LNP-mRNA vaccines, siRNA delivery systems, targeted polymeric nanoparticles, or novel nanomaterial-based therapeutics, Our services equip your team with high-quality, decision-ready data that turns scientific innovation into actionable development outcomes.

Nanoparticle Evaluation

Why Nanoparticle Evaluation Is Essential for Drug Development

Modern nanomedicine platforms—such as LNPs, polymeric nanoparticles, liposomes, and inorganic nanosystems—offer powerful capabilities for targeted drug delivery and RNA therapeutics. However, these systems introduce unique development challenges that cannot be addressed through traditional small-molecule or biologic workflows. Rigorous cellular and in vivo evaluation is essential to reduce risk, optimize formulation performance, and meet regulatory expectations.

Complex Biological Behavior: Nanoparticles interact with cells, proteins, and tissues in ways that traditional drugs do not. Robust evaluation is required to understand how these interactions influence delivery, efficacy, and safety.

Delivery Efficiency as a Bottleneck: For mRNA, siRNA, and targeted therapies, delivery—not the payload—often determines success. In vitro and in vivo studies reveal whether a formulation can reach the right cells and release its cargo effectively.

Regulatory Expectations: Agencies increasingly require biodistribution, PK/PD, and mechanistic data for nanoparticle-based therapeutics. Early evaluation ensures a smooth regulatory path and reduces the risk of delays at IND submission.

Sensitivity to Formulation Changes: Small adjustments in size, charge, or composition can dramatically alter biological performance. Comprehensive testing helps identify formulation attributes that truly drive therapeutic success.

Cost and Time Efficiency: Early screening of nanoparticle candidates prevents costly late-stage failures. Data-driven decisions at the cellular and early in vivo stages streamline the entire development timeline.

Modality-Specific Requirements: RNA therapies and nanocarriers demand specialized assays to assess expression, knockdown, targeting, and immune activation. Proper evaluation ensures each modality performs as intended in biologically relevant systems.

Our Nanoparticle Evaluation Capabilities

Cellular Evaluation Services (In Vitro)

Mechanistic insight and early-stage screening for nanoparticle performance.

Cellular Uptake & Trafficking

  • Flow cytometry-based quantification of cellular uptake
  • Confocal imaging for intracellular localization
  • Endosomal escape monitoring (colocalization, pH-sensitive probes)
  • Receptor-mediated internalization pathway analysis

Nucleic Acid Delivery & Functional Readouts

  • mRNA translation efficiency assays (luminescence, fluorescence, qPCR)
  • siRNA/ASO-mediated gene silencing efficiency
  • CRISPR/Cas cargo delivery validation
  • Time-course analysis of gene expression dynamics

Cytotoxicity, Biocompatibility & Mechanistic Safety

  • MTT/XTT/CCK-8 cytotoxicity assays
  • ROS generation & oxidative stress profiling
  • Apoptosis/necrosis quantification (Annexin V/PI)
  • Hemolysis & complement activation (for systemic formulations)

Cell-Nanoparticle Interface Characterization

  • Protein corona formation analysis
  • Serum stability studies
  • Nanoparticle behavior under physiological shear stress
  • Interaction with immune cells (uptake, activation markers)

In Vivo Evaluation Services

Translational insights to validate delivery efficiency, safety, and therapeutic potential.

Biodistribution & Pharmacokinetics (PK)

  • Whole-animal fluorescence/bioluminescence imaging
  • Radiolabel-based tracking
  • Organ-level quantification via LC-MS/MS, qPCR, or ELISA
  • Pharmacokinetic modeling (t1/2, clearance, AUC)

Pharmacodynamics & Efficacy Models

Oncology Models

  • Subcutaneous, orthotopic, and metastatic tumor models
  • Tumor growth inhibition & biomarker analysis

Immunology & Inflammation

  • Cytokine profiling, ELISpot, T-cell activation
  • Vaccine & adjuvant response evaluation

Metabolic & Organ-Specific Models

  • Liver targeting, CNS delivery, pulmonary delivery

RNA Therapeutics Models

  • mRNA expression tracking
  • Gene knockdown efficiency

Safety & Tolerability Studies

  • Cytokine release & immune activation risk
  • Histopathology
  • Organ toxicity scoring

Dose Optimization & Translational Modeling

  • First-in-human (FIH) dose prediction
  • PK/PD correlation modeling
  • Comparative performance benchmarking between formulations

Analytical & Physicochemical Characterization Services

Critical quality attribute (CQA) profiling for data-driven formulation development.

Nanoparticle Structural & Morphological Analysis

  • DLS: particle size, PDI, zeta potential
  • Cryo-TEM & TEM imaging
  • AFM / SEM (optional)
  • Morphology and surface characteristic mapping

Encapsulation & Release Behavior

  • Encapsulation efficiency (EE%) & loading capacity (LC%)
  • In vitro release kinetics under various pH/conditions
  • Burst release analysis
  • Serum stability & degradation profiles

Composition & Purity Assessment

  • Lipid composition analysis for LNPs
  • Polymer ratio distribution (GPC/SEC)
  • Residual solvent and impurity profiling
  • Endotoxin and sterility testing (when applicable)

Bioanalytical Support

  • LC-MS/MS quantification of payloads
  • ELISA/qPCR/ddPCR quantification for nucleic acids
  • Proteomics and cytokine profiling
  • Biomarker and mechanistic pathway analysis

Custom Study Design & Strategic Consultation

A value-added service often overlooked by competitors.

Early Feasibility & Proof-of-Concept Design

  • Selection of optimal cell lines and animal models
  • Route-of-administration consultation
  • Dosing strategy and formulation feasibility

IND-Enabling Preclinical Planning

  • Regulatory-aligned study design
  • Risk identification for nanoparticle platforms
  • Data package recommendations

Formulation Optimization Guidance

  • Linking characterization data to biological outcomes
  • Identifying CQAs that drive delivery efficiency
  • Comparative formulation strategy
Service Module Included Capabilities Typical Outputs
Cellular Evaluation (In Vitro) Cellular uptake, cytotoxicity, mRNA/siRNA activity assays, trafficking analysisIC50, uptake curves, confocal images, gene expression data
In Vivo Biodistribution & PK Fluorescence/bioluminescence imaging, LC-MS/MS quantification, organ distributionPK curves, half-life, AUC, organ-level accumulation
Efficacy & Pharmacodynamics (PD) Tumor models, immunology models, RNA activity readoutsTumor inhibition %, cytokine profiles, biomarker changes
Safety & Tolerability Hematology, histopathologyToxicity reports, safety margins, GLP-ready data
Analytical & Characterization Particle size, PDI, zeta potential, encapsulation, releaseStability reports, TEM/cryo-TEM images, CQA profiling

Nanoparticle Platforms and Available Evaluation Capabilities

Different nanoparticle modalities require distinct analytical, cellular, and in vivo evaluation strategies. The matrix below outlines the major nanoparticle types we support and the corresponding testing services available for each platform, helping developers quickly identify the capabilities most relevant to their programs.

Nanoparticle Type Typical Applications Available Evaluation Services
Lipid Nanoparticles (LNPs) mRNA/siRNA/ASO, gene editingCellular uptake, mRNA expression, biodistribution, PK/PD, immunogenicity
Polymeric Nanoparticles (PLGA, PEG-PLGA, micelles) Small molecules, peptides, proteinsRelease profiling, tumor accumulation, stability, toxicity
Liposomes Oncology, anti-inflammatory, vaccinesEncapsulation efficiency, particle stability, tumor targeting
Inorganic Nanoparticles (Au, Fe3O4, silica) Imaging, targeted therapyBiodistribution, clearance, organ toxicity
Protein-based Nanoparticles (exosome, albumin) Biologics, nucleic acidsCargo loading, uptake, in vivo tracing

Step-by-Step Evaluation Process

Discovery Briefing & Study Design

1Discovery Briefing & Study Design

Scope definition, recommended assays, and technical consultation.

Formulation Characterization

2Formulation Characterization

Physicochemical and stability testing.

Cellular Evaluation

3Cellular Evaluation

Uptake, activity, safety.

In Vivo PK/Biodistribution

4In Vivo PK/Biodistribution

Route-specific delivery behavior.

Efficacy & Safety Studies

5Efficacy & Safety Studies

Disease models, PD markers, toxicity.

Comprehensive Reporting

6Comprehensive Reporting

Structured reports with detailed datasets, visualized results, and transparent methodology to support scientific interpretation and project progression.

Advantages of Working With Us

Cross-Disciplinary Expertise

Integrated knowledge across nanotechnology, drug delivery, pharmacology, and RNA therapeutics ensures scientifically robust study designs.

End-to-End Evaluation

From formulation characterization to cellular assays and in vivo pharmacology, we provide a complete continuum of nanoparticle assessment.

Advanced Analytics & Imaging

High-resolution bioanalytical, qPCR, LC-MS/MS, and cryo-TEM platforms deliver precise, publication-grade insights.

Validated Disease Models

A broad panel of oncology, immunology, metabolic, and vaccine models accelerates therapeutic proof-of-concept.

Flexible Engagement Models

Choose single-module assays or fully integrated programs tailored to your development stage.

High Reproducibility & Quality Standards

Rigorous QC and standardized protocols guarantee data you can trust.

Application Areas & Supported Industries

01

Pharmaceutical Companies

  • Nanoparticle-enabled drug delivery optimization for small molecules, peptides, and biologics.
  • Preclinical PK/PD and biodistribution evaluation to support candidate selection.
  • Regulatory-ready data packages for IND filings and global development alignment.
02

Biotechnology Companies

  • Acceleration of LNP, polymeric, and hybrid nanoparticle programs from early screening to in vivo validation.
  • Functional assessment of RNA, gene editing, and targeted delivery platforms.
  • Rapid prototype-to-efficacy workflows for fast-moving therapeutic pipelines.
03

mRNA & Vaccine Developers

  • Comprehensive LNP-mRNA evaluation including expression, immunogenicity, and dose optimization.
  • Biodistribution and immune-response profiling for next-generation vaccines.
  • Comparative formulation benchmarking to support improved potency and durability.
04

Gene Therapy & Nucleic Acid Therapeutics

  • In vitro & in vivo delivery efficiency testing for siRNA, ASO, CRISPR, and DNA/RNA constructs.
  • Guide RNA and cargo integrity evaluation under biological conditions.
  • Off-target, immunogenicity, and safety characterization to de-risk development.
05

Academic Research

  • Custom study design and exploratory mechanistic research for novel nanomedicine concepts.
  • High-resolution imaging and analytical support to publish impactful data.
  • Flexible project structures suitable for grant-funded and collaborative studies.
06

Material Science & Nanotechnology

  • Biocompatibility and cytotoxicity testing for new nanomaterials.
  • Interface behavior and cellular interaction analysis to understand biological performance.
  • Proof-of-concept validation in relevant animal models for translational pathways.
Industry Key Needs How Our Platform Supports Them
Pharma IND-ready datasets, robust PK/PD, formulation evaluationFull preclinical package, disease models, regulatory-aligned reporting
Biotech Fast iteration, prototype screeningRapid in vitro screening + integrated in vivo validation
mRNA/Vaccine Developers Immune response, LNP optimizationImmunogenicity panels, antigen expression, biodistribution
Gene Therapy Delivery efficiency, off-target safetyRNA delivery assays, CRISPR activity, immunotoxicity
Academic/Institute Mechanistic studies, advanced imagingCryo-TEM, mechanistic cell studies, flexible bespoke projects

FAQs

What types of nanoparticles do you evaluate?

We support a wide range of nanoparticle platforms, including lipid nanoparticles (LNPs), polymeric nanoparticles (PLGA, PEG-PLGA, micelles), liposomes, protein-based nanoparticles (exosomes, albumin), inorganic particles (gold, iron oxide, silica), nanoemulsions, and nanocrystals.

Yes. We provide full in vitro and in vivo evaluation for mRNA, siRNA, ASO, CRISPR components, and other nucleic acid therapeutics, including transfection efficiency, gene expression analysis, biodistribution, and immune response profiling.

Typical assays include:

  • Cellular uptake (flow cytometry, confocal imaging)
  • Cytotoxicity and biocompatibility
  • RNA expression assays (qPCR, reporter assays)
  • Intracellular trafficking and endosomal escape
  • Cell viability, apoptosis/necrosis, ROS analysis

We conduct biodistribution and PK/PD studies, efficacy assessments in validated disease models (tumor, immune, metabolic), and safety evaluations including chemistry panels, hematology, and histopathology.

Yes. We offer multiple biodistribution modalities:

  • Fluorescence and bioluminescence imaging
  • Organ-level quantification using LC-MS/MS or qPCR

Let's Advance Your Nanomedicine Program

Advancing a nanoparticle-based therapeutic requires more than isolated assays—it demands a partner who understands how formulation science, cellular mechanisms, in vivo pharmacology, and regulatory strategy converge to shape successful drug development. Our Nanoparticle Cellular & In Vivo Evaluation platform is engineered to provide exactly that level of scientific depth and operational reliability. Whether you are evaluating a new LNP for mRNA delivery, optimizing a polymeric carrier for targeted oncology applications, or validating next-generation inorganic nanomaterials, we offer data-driven insights, validated models, and expert guidance to help you transition from early discovery to preclinical proof-of-concept with confidence. Connect with us today to discuss your nanoparticle program, request a proposal, or schedule a scientific consultation.

* Please kindly note that our services can only be used to support research purposes (Not for clinical use).
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