The purpose of stability testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity and light. Due to their composition, biopharmaceuticals are particularly sensitive to environmental factors, making strict storage conditions necessary for the maintenance of biological activity and product integrity. Data derived from the study enables recommended storage conditions, retest intervals and shelf lives to be established. Therefore, evaluation of the stability of a drug substance and product following real-time and real-condition storage is an essential part of the development of a licensed or registered product. At BioReliance, our experienced Analytical Services Department have developed stability protocols which are designed to meet the requirements outlined by the International Conference on Harmonisation (ICH). In addition, BioReliance can provide custom stability protocols to fulfil the specific requirements of individual manufacturers.

Our Stability Testing and Storage services include:

Stability Protocols
At BioReliance, we work in partnership with our clients to develop stability protocols, which meet the requirements outlined in ICH guidelines.

Storage Conditions
BioReliance offer a full range of stability storage conditions, including accelerated / stress conditions.

Testing Frequency
BioReliance conducts stability studies in accordance with guidelines set by The ICH Harmonised Tripartite Guideline, Quality of Biotechnological Products: Stability Testing of Biotechnological / Biological Products.

Analytical Methods and Validation
BioReliance offer a full method validation service, including solution / autosampler stability.

Analytical Method Transfer
At BioReliance we provide our clients with appropriate transfer protocols and we can conduct the transfer testing in conjunction with the originating laboratory.