Evaluation of Extractables from Product-Contact Surfaces

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BioPharm International, BioPharm International-12-15-2002, Volume 15, Issue 1

by the Biopharmaceutical Process Extractables Core Team, including Don Miller, Bayer; Bob Seely, Amgen; John Bennan, ComplianceNet, Inc.; Frank Bing, Abbott Laboratories; Heather Boone, Genentech; Jim Fernandez, Fernandez and Associates; and Harold van Deinse, Baxter Healthcare Corporation Potential interactions between a drug product and its packaging or container closure have always been important considerations for parenteral manufacturers. Now ? at a time of increased regulatory interest in extractables, lower limits of detection, and more biopharmaceuticals reaching commercial stage ? the consequences of not evaluating the extractables in your process stream can be significant. Participants from more than 15 biopharmaceutical companies and data collected for more than 25 years were used to develop the parameters of this article.