Carsten Worsøe has a background in analytical chemistry and graduated from University of Copenhagen in 1998. Since then he has been employed at Novo Nordisk as a principal scientist in an analytical R&D department at Novo Nordisk. During his 16 years at Novo Nordisk, his main responsibility has been to develop analytical methods for Leachables and Extractables (L&E) test procedures of new container closure systems and devices under development. Within Novo Nordisk, he has been one of the important person to bring relevant people in packaging materials, toxicology, formulation, regulatory and analytical chemistry together to perform risk assessments and strategies for E&L testing in development and supply projects within parenteral delivery (prefilled cartridges, prefilled syringes and pump infusion systems etc.).


Health authorities are expecting data for Leachables throughout the shelf life and in-use period of a parenteral drug product. Extractable testing is often considered a prerequisite for leachable testing. For parenteral drug products having complex drug product formulations a gap exist between extractables and leachables’ testing. This gap can be closed with the use of the simulated study. The Product Quality Research Institute (PQRI) is currently developing recommendation and best practices for extractable and leachable documentation for Parenteral and Opthalmic Drug Products (PODP’s). The recommendation describes the “simulated” study as a tool to predict actual leachables in the final PODP product at an early drug development phase and thereby reducing the risk for having critical leachables at a late drug development phase. The presentation will describe the simulated study as the optimal study to predict actual leachables in different parenteral drug products including cartridges, vials and prefilled syringes and how it can be used to reduce the risk for having critical leachables and reactions between leachables and formulation components or the active ingredient at a late drug development phase. The presentation will also describe a number of different opportunities on how to perform simulated studies and finally a number of cases will be presented showing the value of the simulated study.

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