Nanomedicines
Nanomedicines 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 nanomedicines through non-clinical and clinical development towards registration.
Your analytical partner providing:
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customised solutions in terms of analytical protocols and innovative technologies throughout non-clinical and clinical development
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a full range of equipment in Chromatography, Mass Spectrometry, Biochemistry, Pharmaceutical Technologies and Microbiology, to meet all the challenges of developing and validating methods
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regulatory, scientific and technical excellence with a problem-solving approach
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compliance with all applicable EMA, FDA and ICH regulations
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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 | |
| pH / Osmolarity (if liquid) | |
| Properties after reconstitution | |
| Water content / residual moisture (if lyophilised) | KF titration (volumetric, coulometric, oven) |
| 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) / (HS-)GC (FID, MS, ECD) / 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) / (HS)-GC (FID, MS, ECD) / 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, MS, ECD) / 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 / Electrochemiluminescence (MSD) / Luminex / Cell-based assays / FACS / Biacore (SPR) |
