Contaminants, additives or degradants may leach out from any single-use plastic bioprocess bags used in the preparation, storage and transport of biopharmaceutical liquids, intermediates and final bulk products, causing contamination of biopharmaceutical drug products. Therefore, an important part of the safety studies associated with these products is the identification of any potential extractables and leachables, as they pose a risk to the cell culture process, and potentially even to patients.
In this document we look at biopharmaceutical safety, identifying and quantifying extractables and leachables from single-use plastic bioprocess bags.
