Nanomedicines Analytical Development
Advanced analytical development for complex nanomedicine formulations
Overview
We are intimately familiar with defining the critical quality attributes (CQAs) of nanomedicines. To evaluate the CQAs of your GMP-produced drug products and to support product development, we utilize state-of-the-art analytical techniques.
We perform ICH-compliant stability testing of nanomedicines, APIs and novel excipients using stability indicating methods. Our expertise covers lipid nanoparticles, liposomes, and microspheres according to product-specific guidelines, with optimization of critical analytical processes and systematic approaches to address long-standing market complaints.
Analytical Techniques Used
Particle Analysis
- Dynamic light scattering (DLS)
- Small-angle X-ray scattering (SAXS)
- Laser diffraction
- Asymmetric flow field-flow fractionation (AF4-MALS)
Advanced Characterization
- Capillary electrophoresis
- Zeta-potential measurements
- Size exclusion chromatography
- Transmission and scanning electron microscopy
Spectroscopy & Molecular Analysis
Nuclear Magnetic Resonance
- Solution-state NMR
- Solid-state NMR
- Diffusion-ordered spectroscopy
Vibrational Spectroscopy
- Infrared spectroscopy (IR)
- Raman spectroscopy
- Surface-enhanced Raman spectroscopy (SERS)
Chromatography & Separation
HPLC/UPLC Analysis
- Reverse-phase chromatography
- Size exclusion chromatography
- Ion exchange chromatography
- Hydrophilic interaction chromatography
Detection Methods
- UV-Vis detection
- Mass spectrometry (MS)
- Charged aerosol detection (CAD)
- Refractive index detection (RI)
Critical Quality Attributes (CQAs)
Physical Properties
- • Particle size distribution
- • Morphology and shape
- • Surface charge (zeta potential)
- • Physical stability
Chemical Properties
- • Drug loading and encapsulation
- • Chemical stability
- • Impurity profile
- • Drug release kinetics
Biological Properties
- • Biocompatibility
- • Cellular uptake
- • Biodistribution
- • Therapeutic efficacy
ICH-Compliant Stability Testing
We perform comprehensive stability testing of nanomedicines, APIs and novel excipients using stability indicating methods. Our stability studies follow ICH guidelines and include:
Environmental Conditions
- Temperature and humidity control
- Light exposure testing
- Accelerated stability studies
Analytical Monitoring
- Physical appearance changes
- Particle size stability
- Drug content and impurities
Applications & Formulations
Lipid-Based Systems
- Lipid nanoparticles (LNPs)
- Liposomes and vesicles
- Solid lipid nanoparticles
Polymer-Based Systems
- Polymeric nanoparticles
- Microspheres and nanospheres
- Dendrimers and micelles
Ready to Develop Your Nanomedicine?
Contact our nanomedicines team to discuss your analytical development needs and CQA requirements.