Reliable characterization data for liposome-based drug delivery systems, from early development to GMP batch release.
Our liposome analytical services provide comprehensive characterization of key physicochemical properties including particle size, polydispersity, zeta potential, encapsulation efficiency, and release kinetics. Using validated techniques such as dynamic light scattering (DLS), high-performance liquid chromatography (HPLC), and cryo-transmission electron microscopy (cryo-TEM), we deliver reproducible data to support formulation optimization, batch release, and regulatory submission.
Services are available from research-use to quality-controlled testing. Our scientists work with you to define the appropriate analytical strategy based on project stage, lipid composition, and intended therapeutic application. All methods are qualified or validated per ICH guidelines, and final reports include raw data, statistical summaries, and compliance documentation.
Key Features
Particle Size & Zeta Potential Analysis
Determination of hydrodynamic diameter, polydispersity index (PDI), and surface charge using laser diffraction and electrophoretic light scattering. Measurements performed across a range of sample concentrations and buffer conditions to reflect formulation behavior.
Encapsulation Efficiency Determination
Quantification of drug loading and unencapsulated drug using HPLC-UV, fluorescence, or colorimetric assays. Methods are optimized for each drug-lipid system and include proper separation techniques (dialysis, ultrafiltration, or size-exclusion chromatography).
Stability & Release Kinetics Profiling
Real-time and accelerated stability studies under defined temperature, pH, and osmotic stress conditions. Release profiles generated using dialysis, Franz cell, or reverse-phase methods, with data modeled to zero-order, first-order, or Weibull kinetics.
Custom Analytical Method Development
Design and validation of fit-for-purpose analytical methods for novel liposomal formulations. Includes robustness testing, specificity studies, and qualification or full validation per ICH Q2(R1) guidelines to support early-phase through commercial testing.
Analytical Techniques
Dynamic Light Scattering (DLS): Rapid measurement of mean particle size and polydispersity index. Suitable for routine quality control and batch-to-batch consistency assessment.
High-Performance Liquid Chromatography (HPLC): Our HPLC platform quantifies drug content, encapsulation efficiency, and lipid components using UV, fluorescence, and ELSD detectors.
Cryo-Transmission Electron Microscopy (Cryo-TEM): High-resolution imaging of liposome morphology, lamellarity, and structural integrity. Provides visual confirmation of size distribution and heterogeneity.
Zeta Potential Measurement: Electrophoretic mobility analysis to assess surface charge, colloidal stability, and potential aggregation risk.
Encapsulation Efficiency & Release Assays: Validated separation and quantification protocols tailored to drug type and lipid matrix. Includes dialysis, ultrafiltration, and size-exclusion techniques.
Workflow
Our analytical engagement follows a structured process to ensure data integrity, traceability, and alignment with your development timeline.
Sample Receipt & Documentation: Upon project initiation, you submit liposome samples along with relevant formulation details and intended use. We log and inspect samples, assign a unique identifier, and initiate chain-of-custody tracking.
Method Selection & Optimization: Based on sample characteristics and defined endpoints, we select or develop analytical methods. For novel formulations, we conduct feasibility experiments to confirm sensitivity, specificity, and reproducibility.
Instrumental Analysis & Data Collection: Qualified analysts perform the agreed-upon measurements on validated instruments. All runs include internal standards, blanks, and controls. Raw data are archived with audit trails.
Data Review & QC Verification: A second analyst reviews all data for consistency, outlier identification, and method compliance. Acceptance criteria are applied per project specifications or regulatory guidelines.
Reporting & Deliverables: A comprehensive characterization report is prepared, detailing methods, raw data tables, statistical summaries, and conclusions. Reports are formatted for internal use or regulatory submission as requested.
End-to-End Traceability
Every sample and corresponding result is tracked through a validated electronic system, ensuring full traceability from receipt to report. This supports audit readiness and facilitates technology transfer.
Quality Assurance
All analytical work is performed under a robust quality management system. Instruments are calibrated, and methods are qualified or validated according to ICH guidelines where applicable. Data integrity is ensured through electronic audit trails, restricted user access, and periodic internal audits.
Services can be delivered under research-use-only (RUO) or quality-controlled protocols. GMP-level projects follow 21 CFR Part 11 electronic record compliance and include raw data archiving, deviation reports, and certificate of analysis. Our team works with you to determine the appropriate quality level for each project phase.
Why Choose Us
Broad Technique Portfolio: Access to DLS, HPLC, cryo-TEM, zeta potential, and release kinetics assays in one integrated platform, eliminating the need to coordinate multiple vendors.
Regulatory-Ready Data Packages: Reports are formatted to support IND/NDA submissions, with full method validation documentation and audit-trail traceability for GMP projects.
Experienced Scientific Team: Our analysts have extensive experience with liposomal and lipid-based systems, enabling efficient method development and troubleshooting.
Flexible Service Models: Engagements can be scoped for a single analytical endpoint (e.g., encapsulation efficiency) or a full characterization panel. Services are available on a fee-for-project basis with no long-term commitment.
Backed by Creative Biogene: All projects are delivered under Creative Biogene's ISO-aligned quality system, with dedicated project management, milestone-based reporting, and full intellectual property protection for your data.
Liposome Types Analyzed
Our analytical methods are compatible with a wide range of liposome formulations. Representative types include:
Conventional Liposomes: Classic phospholipid bilayers encapsulating hydrophilic or lipophilic drugs. Suitable for basic stability and EE studies.
PEGylated (Stealth) Liposomes: Surface-modified with PEG to prolong circulation time. Analysis includes PEG quantification and assessment of steric barrier integrity.
Cationic Liposomes: Positively charged formulations used for nucleic acid delivery. Zeta potential and aggregation propensity are key parameters.
Stimuli-Responsive Liposomes: pH-, temperature-, or enzyme-sensitive designs.
Contact Us
Whether you are screening carriers, refining lead candidates, or building a regulatory package, the scientific team at Creative Biogene can help you design the right experimental strategy—from formulation and assay selection to data interpretation. Reach out to discuss a tailored solution for your next project.
