SERVICES
Stability Storage and Testing
A particular strength of Melbourn Scientific is the design and implementation of stability studies, with over 20,000 litres of ICH storage capacity and over 20 years experience in stability study management.
Stability studies are designed to provide evidence on how the quality of drug product will vary when it is exposed to a variety of environmental factors such as temperature, humidity and light at various stages of a product lifetime.
Data generated helps to establish either a retest period for a drug substance, or a shelf life and recommended storage conditions for a manufactured product, and are thus essential to minimise market risk.
As real time data are required, these studies can be on project critical paths so any delays will adversely affect submission dates. For these reasons the active involvement of an experienced partner can offer significant benefits.
Stability studies are ideally suited to outsourcing because they are:
- resource intensive with peaks and troughs of activity
- samples need to be stored securely over several years with intensive testing in the early stages
- a vital part of the documentation for any drug submission
Melbourn Scientific has specialist knowledge of stability studies:
- Stability testing is part of our core business
- A significant investment has been made in cabinets, controlled environment rooms and other specialist equipment for ICH and client defined conditions
- Capacity and long-term security for studies lasting 5 or more years
Stability Testing
Stability studies can be on project critical paths so any delays will adversely affect submission dates. The active involvement of an experienced partner can offer significant benefits and the trials are ideally suited to outsourcing:
Stability studies are resource intensive with peaks and troughs of activity. Samples need to be stored securely over several years with intensive testing in the early stages.
Melbourn are ideally placed to manage these studies and provide the accurate real time data that is required as part of the documentation for any drug submission.