Nanomedicine Products

Nanomedicine products are highly diversified in terms of structure, components, drug load or targeting moieties. In a regulatory landscape which is not well defined, this diversity is very challenging for drug developers who have to fully characterise and control the quality of their product, as well as for competent authorities who have to evaluate each project on a case-by-case basis.

Each nanomedicine is unique and requires sound analytical expertise, innovative technical solutions and, above all, real extensive scientific support.

Quality Assistance provides this support, using a customised approach to help you move your nanomedicine products through non-clinical and clinical development towards registration.

Your analytical partner providing:

  • customised solutions in terms of analytical protocols and innovative technologies throughout non-clinical and clinical development

  • a full range of equipment in Chromatography, Mass Spectrometry, Biochemistry, Pharmaceutical Technologies and Microbiology, to meet all the challenges of developing and validating methods

  • regulatory, scientific and technical excellence with a problem-solving approach

  • compliance with all applicable EMA, FDA and ICH regulations

  • GMP, GLP, GCLP/GCP environment

Your one-stop shop for analytical services

Outsource your analytical needs on one site for more efficiency including:

  • Analytical development
  • Validation of analytical methods as per ICH guidelines
  • Characterisation
  • In vitro leakage/release assessment studies
  • Stability studies
  • Batch testing
  • Bioanalytical services
GENERAL QUALITY
Appearance Properties after reconstitution
pH / Osmolarity (if liquid)  
Water content / residual moisture (if lyophilised) KF / Coulometer
Particulate matter Optical microscopy / Light obscuration / Imaging Particle Analysis
Properties after reconstitution  
QUANTITY
Free, encapsulated and total drug (U)HPLC (UV, DAD, RI, fluorescence, ELSD,CAD, conductimetry, PAD, MS) / GC (FID, ECD, MS, headspace) / Capillary electrophoresis (UV, LIF) / ICP (OES, MS) / Titration
Nanomedicine component
PURITY & INTEGRITY
Size and size distribution DLS/A4F-MALLS
Surface charge / Zeta potential DLS
In vitro leakage (plasma, pH, ultrasound) (U)HPLC (UV, DAD, RI, fluorescence, ELSD, CAD, conductimetry, PAD, MS) / GC (FID, ECD, MS, headspace) / Capillary electrophoresis (UV, LIF) / ICP (OES, MS) / Titration
Degradation products
PROCESS-RELATED IMPURITIES
Residual solvents HS-GC (FID, MS, ECD)
Elemental impurities ICP (OES, MS)
Residual components (U)HPLC (UV, DAD, RI, fluorescence, ELSD,CAD, conductimetry, PAD, MS) / GC (FID, ECD, MS, headspace) / Capillary electrophoresis (UV, LIF) / ICP (OES, MS) / Titration
Microbiology Bioburden / Sterility (filtration, direct inoculation)
Endotoxins LAL (kinetic, end point), Monocyte Activation Test
PACKAGING
Container Closure System Integrity Bubbling / Dye ingress / Microbial ingress
Cytotoxicity / Biological reactivity Cell-based assays / USP <87>
POTENCY
For Nanomedicine products with targeting moieties
Immunoassays / Cytotoxicity / Proliferative / Cell death / Cell migration / Cell receptor binding and activation / Reporter gene assays / etc. ELISA / ECL (MSD) / Luminex / Cell-based assays / FACS / Biacore (SPR)
Download the product sheet for more information