Nanoparticle Analysis in Pharmaceutical Products

Pharmaceutical nanoparticles are being developed for a range of healthcare product applications including drug delivery, controlled release systems and medical devices. Lipid-based or polymeric and inorganic nanoparticles can be tailored to enable drug delivery for highly complex therapeutic products including mRNA, oligonucleotides, gene therapies and other biologic drugs. These products present multiple challenges for product characterisation that require sophisticated analytical techniques operated by experienced analysts in order to drive robust data and the insight you need to support your drug development activities. 

Covering both physical and chemical analysis expertise, our nanoparticle experts provide comprehensive R&D or Good Manufacturing Practice (cGMP) compliant analytical capabilities for nano-sized systems for both particles or suspensions. We have supported clients across a range of applications including nanoencapsulation of active ingredients (APIs), lipid nanoparticles (LNPs) for drug delivery or dispersed metallic nanoparticulate systems applied to diagnostics applications. Bringing quality and safety to life, we offer Total Quality Assurance expertise to help you to meet and exceed quality, safety and regulatory standards. 

RESOURCES:

• eBook | Delivery Technologies for Oligonucleotide Therapies
• Article | Physicochemical Properties of Liposomal Advanced Drug Delivery Technologies

Physical Characterization:

• Analysis of particle size and morphology using electron microscopy (SEM and TEM)
• Particle size determination using light scattering techniques or disc centrifugation
• Zeta potential measurements for nanoparticle interactions to aid formulation development 
• Physico-chemical properties (viscosity, solubility and more)
• Surface area and porosity measurements by BET isotherm
• Crystal morphology by powder X-Ray Diffraction
• Controlled release laboratory investigations

Chemical Characterization:

• Organic component analysis e.g. by using liquid chromatography - mass spectrometry (LC-MS/MS)
• Inorganic elemental analysis by inductively coupled plasma spectroscopy (ICP-MS, ICP-OES) or electron microscopy with energy-dispersive X-ray spectroscopy (SEM-EDX)
• Chemical information via FTIR or RAMAN spectroscopy/microscopy or nuclear magnetic resonance (NMR) spectroscopy
• Purity and impurities

Other Nanotechnology Services:

• Nanoemulsion structure by cryo-SEM
• Nanoparticles and nanoemulsions in dispersed systems by Dynamic Light Scattering (DLS)
• Bioanalysis for nanoparticles
• Biopolymer and biologic nanoparticles
• Aggregation behavior of particles in solution
• Regulatory consultancy for nanotechnology products
• Guidance addressing potential health and environmental effects of nanomaterials