Product stability is important to determine shelf-life, the duration for which the product is effective and safe for use. A longer shelf-life is beneficial for managing the supply chain and is often preferred by consumers.
We work with clients to support their product stability requirements from business continuity and storage only to full study management to support new drug applications.
We hold a total of 60,000 litres of capacity to store at the following ICH conditions – 25°C/60%RH, 30°C/65%RH, 30°C/75%RH and 40°C/75%RH as well as bespoke conditions on request.
For storage only customers, once the pull dates are agreed, we can arrange for next day delivery to expedite receipt of your samples.
Collection of samples for the start of a stability study or for contingency, in the event your own facilities go into failure, can be arranged on request.
Our clients who receive both stability storage and testing services will gain secure access to our web portal. From here, you will be able to track progress of your stability study and timepoints, retrieve test data, export your data to excel, trend data and retrieve reports that we issue to you. Our systems are full validated and 21 CFR Part 11 compliant with the implementation of electronic signatures.
Wondering how we can help on your drug development pathway? Download our infographic to see where our services can support you from product concept to commercialisation.
Thank you to the Royal Society of Chemistry for hosting a successful event by JPAG on Stability Challenges. Here, I will share with you some of the latest topics in industry that were highlights of the event.
Download our case study to read how we helped our client maintain regulatory compliance and extend product shelf-life through our method development, validation and stability management service.