Forced degradation studies (also known as stress testing or purposeful degradation) are an important part of any new drug development process. Within the ICH Guideline Q1A (R2) forced degradation studies are split into two main areas:
- Drug Substance
- Drug Product
The purpose of these studies is to gain a good understanding of the chemical and physical stability of drug substance and drug product at an early stage of the drug development process.
Astech’s Flexible Experiment Workcell and Mini Flex Workcell provide a flexible solution for automating your forced degradation studies. Although the physical tests carried out within forced degradation are generally the same, the parameters and methodologies differ from company to company. Whether you’re carrying out degradation tests on drug substance or drug product The Flexible Experiment Workcell and Mini Flex Workcell are easily tailored to meet your specific requirements.
Examples of equipment that can be integrated into each system for the purpose of forced degradation studies are:
- Powder Dispenser
- Liquid Handler
- Laboratory Ovens
- Photostability Test Chamber
- Humidity Chambers
All experiments are designed, scheduled and tracked through our intuitive software solution which is tailored around your needs to ensure that it is user friendly for all staff that will be operating the system.