Analytical Development
and Validation.
Identification, development, monitoring and quality control testing of your product
Expertise
Our Leadership team has extensive collective experience in steering products from pre-clinical to commercial manufacture.
Science-led
Our approach is scientific, collaborative and open, ensuring an open dialogue and transparency that fits your project.
Award-winning
We are a leading CDMO recognised for numerous awards including a King's Award For Enterprise.
Nimble
We adapt to your project needs, and pledge to never relegating it to the bottom of the list.
Analytical Research and Development
API behaviours and insight.
Our scientists recognise that successful development programmes begin with a thorough understanding of the physico-chemical characteristics of the API, and any potential stability or excipient incompatibility challenges.
Using a range of techniques including, DSC, TGA, XRPD, Microscopy, FTIR, Particle sizing. etc. we gain a fundamental understanding and insight into the behaviours of your API to support the development activities required for First in Human studies and product development.
- Material Identification
- Solubility Screening
- Excipient Compatibility
- Physio Chemical characterisation
- Support or enabling protocols UpperSolv™, PulmoCraft™ and UpperNose™
Analytical and Quality Control Services
Phase appropriate validation.
Once your product enters clinical development our dedicated team of analytical experts work with you and our cross functional teams to transfer, development, and phase appropriate validation of your analytical methods and performance of QC and release testing including:
- Assay, Content uniformity and related substances by HPLC
- Performance testing including Dissolution and Disintegration
- Moisture and residual solvents
- IC Stability testing
- Cleaning verification
- DoE studies to investigating critical process parameters
Key equipment and techniques
Analytical Techniques
- Differential Scanning Calorimetry (DSC)
- Thermal Gravimetric Analysis (TGA)
- Dynamic Vapour Sorption (DVS)
- X-ray Powder Diffraction (XPRD)
- Scanning Electron Microscopy (SEM)
- Raman Spectroscopy
- High Performance Liquid Chromatography (HPLC)
- Liquid Chromatography – Mass Spectrometry (LCMS)
- Ultra Violet Gas Chromatography (UVGC)
- Fourier-transform Infrared Spectroscopy (FTIR)
- Karl Fischer
- Dissolution Apparatus I and II
Analytical Services Information Sheet
Download now to learn more about our analysis and testing services.
PDF
