Stability assessment is an important part of the assessment of the vaccine quality and safety subject to detailed regulatory oversight. The purpose of the stability assessment is to ensure that the vaccine is of acceptable quality and thus has satisfactory safety and efficacy at the end of its shelf life or storage period under recommended environmental conditions. Assessment of vaccine stability is complex because they are very susceptible to inactivation by environmental factors. Potency should be measured as a part of the stability testing, except in those cases where potency testing based on biological activity is not possible. Physical and chemical product characterization should be included in the stability assessment. For a product entering human clinical trials, sufficient data should be collected to support the stability of the product for the duration of the preclinical and clinical trial.
Alfa Chemistry offers the following two types of stability assessment services.
- Real-time stability assessments
The stability of a vaccine, and therefore the proposed shelf-life, expiry date and storage conditions should be determined on the basis of the results of real-time stability assessments. In real-time stability assessments, vaccines are stored and monitored until it fails vaccine specifications.
- Accelerated stability assessments
In addition to real-time stability data, accelerated stability assessment data of vaccines under elevated stress conditions (e. g., high temperature and / or humidity) can also be used to support preliminary data obtained at normal storage temperatures.
Why choose us
Alfa Chemistry can perform stability studies on vaccines to determine the storage period of intermediates, to determine or modify a maximum shelf-life or minimum release specification for final product, and to monitor vaccine stability post-licensure. By utilizing our experienced experts to work with your team, Alfa Chemistry helps you assess the stability of your vaccines at different stages of development. If you have any questions related to stability assessment, please feel free to contact us. Alfa Chemistry is always your project partner.
Our products and services are for research use only and cannot be used for any clinical purposes.