Centralise your analytics

       

Nanomedicine Products

Nanomedicine products are highly diversified in nature and properties.
Moreover few guidances exist to show the way towards registration.

Thanks to over 30 years’ experience in analytical sciences and over 10 year’s in nanomedicine products, Quality Assistance assists you to design and carry out your nanoparticle characterisation studies, development and validation of analytical methods for your liposomal product, etc., in short for all analytical development work you may need.

nanomedicine-quality-assistance

These methods in hand, our team analyzes 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.

 

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Our capabilities in this area are summarized in the following table:

Characterisation
General properties Size and size distribution
Zeta potential
Internal environment characteristics
Drug load characterisation Total, free and encapsulated drug quantification
Nanomaterial components Quantification of nanomaterial components and their degradation products
In vitro leakage Conditions
  • pH
  • Temperature
  • Ultrasounds

Matrices

  • Buffers
  • Plasma
Characterisation of targeting moieties

Cell-based assays
Ligand binding assays

Batch release and stability studies
General quality Appearance
pH / Osmolality
Water content / residual moisture
Particulate matter
Quantity Free drug and total drug
Nanomaterial components
Purity and integrity Size and size distribution
Surface charge / zeta potential
In vitro leakage
Degradation products
Process-related impurities Residual solvents
Elemental impurities
Residual components
Microbiology
Endotoxins
Potency (nanomedicine products with targeting moiety) Cell-based assays
Ligand binding assays
Packaging Container closure system integrity
Cytotoxicity / biological reactivity
Bioanalysis
Drug and metabolites Free drug / Encapsulated drug / Total drug
Targeting moieties
Nanomedicine products
Immunogenicity Anti-drug antibodies
Screening and confirmatory assays
Neutralising assays
GLP formulation studies Buffers
Vehicles
Biomarkers Small molecules
Peptides
Proteins


You can download the brochure

 

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