Pharmaceutical Analysis
Our large, experienced inhalation group of analytical scientists can undertake the comprehensive array of test methodologies and physical properties characterization required to support the development of inhaled products.
With extensive, state-of-the-art analytical testing facilities and equipment, our expert teams are able to develop and validate the methodologies required to characterize inhaled delivery platforms, especially DPI, pMDI and nebulized products.
To ensure seamless support, we also offer:
- Comprehensive stability storage facilities to support small bespoke stability studies and large pivotal programs
- Deep experience of developing pharmaceutics, device verification testing and authoring CMC sections for regulatory submissions
Our comprehensive analytical services include:
- Conventional chromatography and aerosol characterization using HPLC, UPLC, GC, cascade impaction, delivered dose analysis and spray-pattern testing
- LC detection capabilities include UV and UV diode array, fluorescence, refractive index, charged aerosol detection (CAD) and mass spectroscopy
- Physico-chemical (Q3 type) methods capability, including more realistic testing using throat models and patient inhalation profiles, and dissolution profiling and blend microstructure measurements, which are key to understanding equivalence for generic programs or bridging between devices and formulations
- Dedicated physical properties capability, including Morphologi 4-ID automated particle size/shape analysis and surface properties measurement, differential scanning calorimetry (DSC), and scanning electron microscopy (SEM)
- Biologics evaluation methodologies, including SDS-PAGE electrophoresis, plate-based assays, isoelectric focusing, dynamic light scattering and zeta potential
- Solution physico-chemical properties measurements for liquid formulations (rheometry, viscometry, osmolality, surface tension)
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