Nanomedicines
Nanomedicines are among the most innovative and versatile strategies in modern drug delivery. From small molecules encapsulated in liposomes to mRNA formulated in lipid nanoparticles, these advanced systems offer enhanced therapeutic efficacy, controlled and targeted release and reduced systemic toxicity.
A cross-disciplinary challenge in drug delivery
Developing nanomedicines goes far beyond particle engineering. It requires deep, cross-functional expertise in analytical chemistry, biology and material science.
Whether you're working on lipid-based systems, polymeric carriers, inorganic nanoparticles or hybrid nanostructures, our integrated teams support you across the full development lifecycle: from early-stage characterisation and formulation optimisation to batch release and stability studies. With cutting-edge analytical platforms and a collaborative mindset, we help you transform promising concepts into safe, effective and scalable therapies.
Our analytical expertise for nanomedicines
Because nanomedicines bridge formulation science, small molecules and biotherapeutics analysis, our teams provide tailored support to ensure the quality, stability and performance of your product. We characterise all critical quality attributes of your nanomedicines:
| Residual solvents | (HS)-GC (FID, MS, ECD) |
|---|---|
| Elemental impurities | ICP (OES, MS) |
| Residual components | (U)HPLC (UV, DAD, RI, fluorescence, ELSD, CAD, conductimetry, MS) / GC (FID, ECD, MS, headspace) / CE (UV, LIF) / ICP (OES, MS) / Titration |
| Microbiology | Bioburden / Sterility (filtration, direct inoculation) |
| Endotoxins | LAL (kinetic, end point) / MAT / rFC |
| Container Closure System Integrity | Bubbling / Dye ingress / Microbial ingress |
|---|---|
| Leachables | (HS)-GC (FID, ECD, MS) / ICP (OES, MS) / (U)HPLC (UV, ELSD, CAD, MS) |
| Cytotoxicity / Biological reactivity | Cell-based assays / USP <87> |
| Break Loose and Glide Force (BLGF) for prefilled syringes |
| Immunoassays / Cytotoxicity / Proliferative / Cell death / Cell migration / Cell receptor binding and activation / Reporter gene assays / etc. | ELISA / ECL (MSD) / Luminex / Cell-based assays / FACS / SPR (Biacore) / BLI (Octet) |
|---|
| Free, encapsulated and total drug | (U)HPLC (UV, DAD, RI, fluorescence, ELSD, CAD, conductimetry, MS) / (HS)-GC (FID, MS, ECD) / CE (UV, LIF) / ICP (OES, MS) / Titration |
| Nanomedicine component | (U)HPLC (UV, DAD, RI, fluorescence, ELSD, CAD, conductimetry, MS) / (HS)-GC (FID, MS, ECD) / CE (UV, LIF) / ICP (OES, MS) / Titration |
| Nanomaterial components degradation products | (U)HPLC (UV, DAD, RI, fluorescence, ELSD, CAD, conductimetry, MS) / (HS)-GC (FID, MS, ECD) / CE (UV, LIF) / ICP (OES, MS) / Titration |
| API degradation products | (U)HPLC (UV, DAD, RI, fluorescence, ELSD, CAD, conductimetry, MS) / (HS)-GC (FID, MS, ECD) / CE (UV, LIF) / ICP (OES, MS) / Titration |
| Study of drug leakage or release in different conditions: pH, temperature, in plasma, ultrasound at defined temperatures | (U)HPLC (UV, DAD, RI, fluorescence, ELSD, CAD, conductimetry, MS) / (HS)-GC (FID, MS, ECD) / CE (UV, LIF) / ICP (OES, MS) / Titration |
Advanced analytical expertise for nanomedicines
At Quality Assistance, most of our analytical services can be applied to nanomedicines. Our single-site model brings together complementary technologies to ensure a comprehensive understanding of your product’s performance.
- Size, distribution and morphology: DLS, SEC/MALS, AF4/MALS, Micro-Flow Imaging
- Colloidal stability: Laser Doppler Micro-electrophoresis (zeta potential)
- Drug quantification: (U)HPLC–UV/DAD/ELSD/CAD/MS, ICP–MS
- Impurity profiling: (HS)-GC, ICP–MS/OES, (U)HPLC
Bioanalytical services
We support your nanomedicine programs from non-clinical to clinical phases, under full GLP/GcLP compliance:
- Quantification of free, encapsulated, and total drug
- Pharmacokinetic and toxicokinetic profiling
- Immunogenicity and biomarker analysis
Our orthogonal platforms include: (U)HPLC-MS/MS, ICP-MS, ELISA, MSD, Luminex, Biacore (SPR)
| Anti-drug antibodies (ADA) | ELISA / SPR (Biacore) / BLI (Octet) / ECL (MSD) / Luminex |
|---|---|
| Screening and confirmatory assays | ELISA / SPR (Biacore) / BLI (Octet) / ECL (MSD) / Luminex |
| Neutralising assays | FACS / Cell-based with different readouts (fluorescence, luminescence, flow cytometry) |
| Vehicles / Buffers | UV / (U)HPLC (MS/MS) / ICP (MS) / ELISA |
|---|
| Biomarkers | U(H)PLC (MS/MS) / ELISA / ECL (MSD) / Luminex / SPR (Biacore) / BLI (Octet) |
|---|
Related services
Your trusted partner in nanomedicines
At Quality Assistance, we bring over 20 years of experience supporting your nanomedicine with customised analytical strategies. Our integrated approach combines:
- Cross-product expertise: shared methodologies with mRNA, oligonucleotide, and NCE programmes
- Integrated single-site model: scientific continuity and full data traceability
- Advanced technology platform: all analytical techniques under one roof
- Regulatory compliance: full GxP certification and deep understanding of EMA/FDA expectations.
- Proven experience: decades of analytical support on nanomedicine and liposomal formulations, including cytotoxic drugs and targeted delivery systems.
Advance with confidence through analytical precision
Partnering with Quality Assistance means gaining access to a robust infrastructure, cutting-edge technologies and a team committed to scientific excellence. Let's unlock the full potential of your nanomedicine together.