Data-driven approach to establish a design space for raw materials properties and manufacturing conditions for pharmaceutical drug stability assurance
Pharmaceutical companies are required to perform stability testing of their drug products by regulation. A drug product that succeeds on stability testing means that its identity, potency, and purity remain within pre-established limits over its shelf life. Nowadays, drug products are more frequently reformulated in response to a highly competitive market, new research discoveries and the availability of new suppliers of raw materials. It is therefore increasingly challenging for the formulator to assess the impact that a change in raw material suppliers or in the proportions of different types of materials will have on the stability of the product. The proposed research aims at developing a joint specification region for selecting raw materials to assist the formulator ensuring product stability in spite of unavoidable changes in raw material properties and modifications to their ratios. Large historical drug product manufacturing databases and multivariate statistical methods will be used for establishing the specification region. Such a proactive tool will help pharmaceutical companies avoid or reduce the occurrence of stability issues caused by inadequate combinations of raw materials, mitigate the risks of drug product recalls while reducing raw materials purchasing costs.