Stability & Storage
We can help you with stability testing programs for drug substances and drug products that meet the requirements of the ICH Guidelines Q1A-F and Q5C.
We compile stability protocols containing the stability specifications and the chosen methods, justified as stability indicating. Each stability study is specifically designed to your project needs with analyses of those attributes that are susceptible to change during storage. Prior to stability testing it might be necessary to establish the stability indicating capacity of some methods. We can support your project with a range of stability indicating methods that enables us to perform complete studies under long-term, intermediate and accelerated conditions.
Our stability testing services include:
- Initial testing of stability indicating methods
- Long-term, intermediate and accelerated stability studies
- Forced degradation studies
- Freeze-thaw stability studies
- Photostability testing
- Shipment simulation studies
Intermediate substances, created during the manufacturing of drug substances, may not be immediately processed. In these cases stability testing may be required. For example, the stability of inclusion bodies has to be demonstrated from isolation to downstream processing.
We can offer you a wide range of storage conditions according to ICH Guideline Q1A or any custom requirement:
25 °C at 60% RH
30 °C at 65% RH
40 °C at 75% RH
The cooling devices and climatic exposure cabinets are equipped with data loggers permanently recording temperature and humidity. Additionally, all devices are connected to a 24/7 alarm system.
For cell banks identity, purity and cell growth characteristics used for analytical purposes are checked according to a pre-defined stability protocol containing the stability specification and justifying the chosen methods as stability indicating.
Characterization and stability testing of prokaryotic and eukaryotic cell banks:
- Identity (phenotypical/morphological), e.g. API20
- Identity (genotypical), e.g. plasmid sequencing, restriction analysis
- Identity/content, e.g. plasmid copy number
- Purity, e.g. phage assays,mycoplasma assay, SMRV assay
- Growth characteristics, e.g. viability, G/d value
- Cell bank storage
REFERENCE AGENTS AND KEY STANDARDS
Regardless of the analytical method, an adequately characterized reference material must be available for the vast majority of analytical assays. For some tests key reagents like antibodies or viruses are required. These need to be maintained in a qualified state.
- Stability and retest programs
- Characterization and assessment of identity, purity, content or titer of the reference material and key reagents