Stability testing according to ICH, forced degradation studies / stress testing and comparability studies
Stability testing and forced degradation studies (stress testing) play a central role during formulation development, developability and manufacturability assessment and analytical method development. We have currently published a review on forced degradation studies in the Journal of Pharmaceutical Sciences, which can be provided to you upon request.
Stability testing, which is performed in suitable climate chambers at controlled temperature and relative humidity) can be offered as part of formulation development projects, supply of pre-clinical material or as independent service package.
Standard storage conditions available at Coriolis Pharma are frozen storage (-80°C, -20°C) and storage according to ICH for liquid and lyophilized products (e.g. 2-8°C, 25°C/60% RH, 30°C, 40°C/75%RH). Other temperature between 4°C and 90°C and relative humidity conditions can be offered as well, e.g. for kinetic studies.
Within Coriolis Pharma we identify and optimize suitable stress conditions for the molecule of interest to be applied in forced degradation studies. The stress conditions are applied during analytical development to identify stability-indicating methods, during formulation development to identify overall robust and stable formulations or for comparability studies.
Examples of typical stress conditions are:
- elevated temperature
- incubation in the frozen state at different temperatures
- mechanical stress studies
- photostability testing according to ICH
- extreme pH conditions
- oxidative conditions
- compatibility studies with various materials (e.g. spiking with silicone oil)
- compatibility with the final administration conditions
Stability testing and forced degradation studies are also included in comparability studies, which are frequently requested by and performed for our customers. The physico-chemical comparability (including stability profile) can be shown, e.g. for one molecule of interest from different production processes, but also for a biosimilar drug with its originator product, just to name two examples.
The service for our costumers includes:
- performing stability studies according to ICH
- performing stability studies at individually selected conditions, e.g. to study degradation kinetics
- setting up, optimizing and performing stress testing (forced degradation studies)
- testing the compatibility with the final administration conditions
- performing comparability studies