Stability studies

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.