Comprehensive Physicochemical Characterization for Nanoparticle-Based Therapeutics Services
Nanomedicine Characterization Service

Comprehensive Physicochemical Characterization for Nanoparticle-Based Therapeutics Services

Our service provides rigorous analytical testing for lipid nanoparticles, polymeric nanoparticles, liposomes, and metal nanoparticles to support regulatory filing and clinical translation.

What We Offer

Our nanomedicine characterization service delivers a full suite of physicochemical and biological quality attributes for nanoparticle-based drug delivery systems. We leverage industry-standard analytical techniques including dynamic light scattering (DLS), transmission electron microscopy (TEM), high-performance liquid chromatography (HPLC), and UV/Vis spectrophotometry to quantify particle size, polydispersity, zeta potential, morphology, encapsulation efficiency, drug loading, and in vitro release kinetics under physiologically relevant conditions.

We serve nanomedicine companies, drug formulation teams, and academic laboratories developing lipid nanoparticles, polymeric nanoparticles, liposomes, and nanosuspensions. Each project is scoped to the specific carrier type and payload, with quality-controlled documentation and a certificate of analysis delivered at project end. Our analytical team works closely with clients to align testing protocols with regulatory expectations for preclinical and early clinical development.

Our Analytical Suite

Particle Size and Zeta Potential

Determination of mean particle diameter, polydispersity index, and surface charge by DLS and electrophoretic light scattering, with results reported per batch and per accelerated stability time point.

Encapsulation Efficiency and Drug Loading

Quantification of encapsulated payload versus free payload using HPLC or UV/Vis methods after separation by ultrafiltration or size-exclusion chromatography, with mass balance confirmation.

In Vitro Release and Stability Profiling

Release kinetics in relevant biorelevant media (PBS, simulated gastric fluid) using dialysis or direct sampling methods, alongside storage stability (4°C, 25°C, 40°C) and freeze-thaw cycle testing.

How It Works

Sample Submission and Review Submit your nanoparticle formulation along with a completed project requisition form. Our scientific team reviews the material composition, payload properties, and intended application to propose a tailored testing plan.
Physicochemical Analysis We perform particle size, zeta potential, and morphology assessment using validated DLS and electron microscopy protocols. Polydispersity and batch-to-batch consistency are evaluated in triplicate.
Encapsulation Efficiency and Release Testing HPLC or UV/Vis methods are employed to measure encapsulation efficiency and drug loading. In vitro release is conducted under sink conditions with frequent sampling over 48–72 hours.
Data Review and Final Report All raw data, analytical method details, and results are compiled into a comprehensive characterization report. A certificate of analysis is issued upon client approval of the final dataset.

Project Deliverables

Deliverable Description
Particle Size Report Mean hydrodynamic diameter, polydispersity index, and size distribution histogram from DLS analysis.
Zeta Potential Report Electrophoretic mobility and zeta potential values measured at specified pH and buffer conditions.
Morphology Images Representative transmission electron microscopy (TEM) or scanning electron microscopy (SEM) images with scale bars and qualitative description.
Encapsulation Efficiency Data Percent encapsulation efficiency and drug loading (w/w) determined by validated HPLC or UV/Vis method.
In Vitro Release Profile Cumulative release curve over time with sampling points, release medium composition, and temperature.

Why Choose Our Service

Broad Platform Coverage

Our analytical suite is validated for lipid nanoparticles, polymeric nanoparticles, liposomes, nanosuspensions, and metal nanoparticles. Testing protocols are adaptable to diverse payloads including small molecules, nucleic acids, peptides, and proteins.

quality-controlled Documentation

All characterization reports include full method descriptions, raw data, and certificates of analysis compliant with ICH Q2(R1) and GMP Annex 1 standards, supporting regulatory submissions and investigator brochures.

Experienced Scientific Team

Our analytical scientists bring over a decade of combined experience in nanomedicine characterization, with deep expertise in method development, method qualification, and troubleshooting complex nanoparticle formulations.

Integrated Analytical Services

Beyond physicochemical testing, we offer complementary services including sterility and endotoxin testing, bioanalysis, and CMC regulatory support, allowing seamless integration under a single project manager.

Further Reading

Analytical characterization of liposomes and other lipid nanoparticles for drug delivery

View article

Ready to Characterize Your Nanomedicine?

Contact our analytical team to discuss your nanoparticle characterization needs. We will provide a project-specific scope and timeline tailored to your formulation and development stage.

Start Your Project
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