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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.

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.

Annual Studies

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.

Accelerated Studies

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.

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.

Photostability

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.

Storage Only

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.

Business Continuity

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.

stability services leaflet

Our Capacity

We hold a total of 60,000 litres of capacity to store at the following ICH conditions – 25/60, 30/65 and 40/75 as well as bespoke conditions on request.

 

How We Deliver

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.

Resources

Infographic

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.

Blog

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.

Case Study

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.