Mass Transport Modelling in support of leachable risk management.
Thomas Egert at Boehringer Ingelheim Pharma and Jason Creasey at Maven E&L Ltd
About this talk
Leachable risk management continues to be of regulatory interest. However we continue to rely on experimental extractable studies as predictors of leachable risk. These are complex to design and implement, and do not always offer the answer to what is the leachable risk for a drug product or medical device. We hope to show that mass transport modelling provide an alternative or a complementary element to testing the leachable risk. There are relatively simple mathematical models which can be developed which might provide an estimate of maximum leaching in a system. These can estimate factors such as solubility, partitioning and diffusion if successfully constructed and in combination these can estimate leaching. There are several ways which these might be modelled and this presentation will discuss each one. The presentation will illustrate where modelling might replace or support current approaches which rely upon experimental study. Results from modelling is complementary to risk appraisal, as predictive modelling gives quick insight into effects of storage time, temperature and other kinetics of leaching. This could be used to screening different materials and predict their leaching characteristics perhaps more effectively and efficiently than current extractable test protocols leading to better leachables studies to confirm these models.
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