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European Biopharmaceutical Review

Exhaustive Extraction




The importance of extractables and leachables testing in the pharmaceutical industry has grown significantly in the last few years, driven by a substantial growth in global regulatory requirements on patient safety and drug product interaction. A drug product container-closure system should not release chemicals that can accumulate in the drug product in quantities sufficient to present a risk of toxicity, or affect its stability or efficacy. Substances may migrate from different materials, and patients may be exposed through different routes of administration. The examination of extractable and leachable substances is extremely relevant for the protection of patients. During the drug development process and study design, it is important to evaluate the potential for various chemicals to migrate. The aim of extractables and leachables testing is to identify and quantify chemical compounds that can be released from packaging interactions with the drug product. Depending on the specific purpose of the extraction study, laboratory conditions applied may accelerate or exaggerate the normal conditions of storage and use for a packaged dosage form in order to obtain the pattern of extractables that can be released.

Below are a list of definitions which will help with the navigation and understanding of this article:

• Extractables: chemical entities that can be released from an item (packaging system, process component, medical device) under laboratory conditions applying specific extraction solvents, temperature, and time of contact
• Asymptotic level of extraction: the situation in which the curve of release of an extractable shows a steady state, and no significant increment is noted between two subsequent checkpoints
• Exhaustive extraction: indicates the level extraction in which the most significant release, in terms of number and amount of extractables, can be considered comprehensive in the scope of the screening

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Simone Carrara currently serves as Extractables and Leachables and Impurity Characterisation Laboratory Manager at Eurofins BioPharma Product Testing in Italy. He holds a Biotechnology degree from the University of Milan, Italy, and has a vast experience as a bio-analytical researcher through LC/MS method development for Pharmacokinetics analysis and ADMET profiling. In his previous role as Project Leader he successfully managed different projects in a wide range of areas, including analytical method development and validation with LC/MS-GC/MS, and drug product impurities characterisation. For the last five years he has been focusing on extractables and leachables studies to support drug-manufacturing companies to fulfil regulatory requirements.

Michele Vasso, PhD, has served as Project Leader of Extractables & Leachables and Impurity-Characterization Laboratory at Eurofins BioPharma Product Testing in Italy since 2016. Michele holds a Biotechnology degree from the University of Naples, Italy. He received the PhD in Molecular Medicine from the University of Milan in 2009. During this period he consolidated his expertise as bio-analytical researcher in mass spectrometry. He joined the Italian National Research Council (CNR) as a researcher where he was involved in relevant projects on method development by mass spectrometry (LC/MS and MALDI/MS) for the characterisation of biological molecules and low-weight compounds. After joining Eurofins BioPharma Product Testing Italy, his main expertise lies in extractables and leachables studies.
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