A full suite of process, performance and stability testing to ensure against failure
The development and use of suitable analytical techniques is a critical part of product development and is needed to test all aspects of the formulation pathway from the incoming API through to testing the final dosage form produced in the GMP plant.
Comprehensive physical and chemical analysis enables our scientists to build an understanding of the how the API, spray dried powder and the final dosage form behaves; in terms of retention of functionality, assessment of product performance and storage stability.
Whether the formulation contains a traditional small molecule API or a complex biological molecule, Upperton has the experience to undertake even the most rigorous of testing regimes.
When analytical testing methods are transferred from R&D into our QC laboratories there is always a need to undertake appropriate assay validation to ensure that the analytical methods used are fit for purpose. This is an integral part of assay transfer and something we have undertaken many times.
Key Analytical Techniques
- Laser diffraction to determine the particle size and size distribution, which are especially important when targeting pulmonary or nasal delivery.
- Scanning Electron Microscopy (SEM) is used to assess particle morphology.
- Differential Scanning Calorimetry (DSC) generates important information about the amorphous or crystalline nature of the formulation components and their phase behaviour. The glass transition temperature can be a good indication as to the stability of the formulation.
- Dynamic vapour sorption (DVS) is a gravimetric technique that measures the uptake and loss of water by a sample at a range of controlled humidity conditions. This gives important information regarding the response of the sample to humidity which is particularly important when considering sample handling and packaging .
- High performance liquid chromatography (HPLC) is commonly used for assay of API and degradants in the formulation.
- Loss on Drying is typically used to determine moisture content. This can be at elevated temperatures using a simple moisture balance, or at 0% relative humidity using the DVS.
- Dissolution in a range of pH media is performed using USP apparatus I and II.
- Characterisation of powder flow properties using a range of testing equipment.