PX'Therapeutics proposes stability studies on proteins and cell banks at different steps of product development.
A certificate of analysis is delivered at the end of each study.
Stability studies are performed using relevant analytical methods with the objectives of:
Following the product degradation, loss of activity, loss of cell viability, etc.
Determining the best storage form
Determining the Drug Product’s expiration date
PX'Therapeutics performs stability studies on Drug Substances and Drug Products according to ICH Q5C guidelines:
Long-term study (real temperature of storage) < –70°C or < –20°C
Accelerated study 5 ± 3°C
Stressed study 25 ± 2°C
All studies are performed in dedicated and monitored incubators.
PX'Therapeutics guarantees the storage of your samples throughout the stability studies.