- Stability storage is provided in dedicated purpose built walk-in climatic chambers located in a controlled area. The chambers are controlled via a fully validated data management system in accordance with FDA requirements and ICH harmonized guidelines for stability testing of new drug products and substances. Each chamber is temperature and humidity controlled to +/-2°C and +/-5%RH of its target conditions, with 24hr monitoring of chamber conditions.
We are experienced in offering stability services across the following subject areas:
New Drug Development
- As part of your submission, stability data is a key aspect in providing evidence of your product’s efficacy and safety over time. We frequently collaborate with clients and support their drug development pathway from raw materials to finished products and identifying suitable intermediates to bulk up as you go into manufacturing. For each key intermediate we place on stability to observe how the product decomposes and assess if the degradants are harmful.
- We conduct accelerated studies on a product to preview the potential degradation process in a shorter period. These studies support the development of a product’s stability profile and are an efficient way to highlight and troubleshoot problem areas early.
- Regulations require license holders to conduct annual stability studies to monitor product quality during routine manufacture. Our team works closely with clients to ensure annual studies are conducted and the necessary data is captured and reported to maintain compliance.
Excursion and Transit Studies
- Quite often product is manufactured in a different country than the destination. In route, the storage conditions can reach outside tolerance and pose a risk to product safety and efficacy. Therefore, our team is here to support you by conducting excursion studies. We will provide you a full analysis on the quality of your product during exposure to a rise in temperature and humidity.
- Providing photostability data is a standard requirement for any new drug application. We have the capacity to support your photostability requirements and provide you with a full analysis from direct exposure to exposure in final packaged product. At the end of each exposure period, we examine physical changes and report assay and impurities which are likely to arise from photochemical degradation processes.
- We also work with clients who have storage only requirements. They may need a special condition for which they don’t have the capacity, or they simply don’t have the space or budget to house their own stability chambers. We can pull and ship in the same day, accommodate next day delivery, and we can also accommodate controlled shipping conditions.
- Having a plan in place in the event of a disaster is general good practice for any business. We offer business continuity support to our clients detailing transfer protocols that can be executed within an agreed time frame should a disaster occur.