Nanomedicine Products

Each nanomedicine is unique and requires sound analytical expertise, innovative technical solutions and, above all, real extensive scientific support. Quality Assistance assists you to design and carry out your nanoparticle characterisation studies, development and validation of analytical methods for your nanomedicine product.

These methods in hand, our team analyses your batches for release or stability purpose to support your IMPD/IND.

Along (non) clinical studies, through the analysis of samples, Quality Assistance helps you to determine the pharmacokinetic profile of your nanoparticle in animal and human matrices.

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
  • Bioanalysis
GENERAL QUALITY
Appearance  
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 drug 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)
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 / ELISA / ECL (MSD) / Luminex / Cell-based assays / FACS / Biacore / Cell death / Cell migration / Cell receptor binding and activation / Reporter gene assays / etc. ELISA / ECL (MSD) / Luminex / Cell-based assays / FACS / Biacore
Download the product sheet for more information