Stability Studies

Stability studies play a vital role in the development of drug products. According to the ICH Q1A guidelines, “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.” This helps to establish the shelf life of a drug product during storage, suitable storage conditions, and a re-test period for the drug substance. Notably, biologics, biosimilars, viruses, vaccines, and biofunctionalized devices are especially susceptible to the influence of environmental factors during processing, transport, storage, or handling.

Stability studies evaluate the stability of a DS or DP under various conditions such as temperature, light, or mechanical stress over time. An evaluation encompassing both in-vitro and in-silico methods as an integrated approach enables a comprehensive understanding of the product's stability profile. In-silico methods can give you prediction power which can shorten your development timelines. Leukocare specializes in providing these advanced testing and prediction techniques. Our team performs stability studies according to ICH Q1A guidelines and can support the data set for registration applications.

Stability Study Expertise

With more than 20 years of scientific and regulatory experience, and guided by the internationally recognized ICH Q1A-E guidelines, our team executes stability studies with precision, generating robust data that not only assures product stability but also serves as a valuable asset for registration applications.

Stability testing services cover temperature stress (Freezer and ICH Q1A storage cabinets covering temperatures from -80 °C to +40 °C), light stress to assess photostability (ICH Q1B light tester) and various models of mechanical stress. With a broad analytical toolbox optimized for stability indicating analyses of the CQAs, we evaluate the stability at specific time points. For long-term stability prediction, we can provide regression analysis (linear and multiple) and kinetic modeling based on either in-house stability data or data from your GMP laboratory. With kinetic modeling, we can even extend the quality of extrapolation even beyond ICH Q1E guidelines.

In essence, stability studies stand as a cornerstone of our commitment to delivering drug products that endure the test of time and environmental challenges.