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A number of risks to biologic drug products can arise from poorly understood packaging materials, components, or systems. Examples of risk include: presence of elemental impurities or other leachables, particulate contamination, product aggregate formation, and compromised container closure integrity. Taking a scientific approach to fully understand the chemical characteristics of packaging materials and subsequently evaluating component and system safety in both simulation and actual conditions of use studies will enable the most robust assessment of potential risks to biologic drug products. The presentation also provided an update on the efforts of the Leachables and Extractables Working Group of the Product Quality Research Institute (PQRI).
Please click here to view Ms. Paskiet’s presentation. It is also available in the Knowledge Center of our website.
More information about PQRI can be found here.