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The use of disposable equipment in the biopharmaceutical industry is rapidly increasing and in disposable cell culture systems, the bioreactor vessel commonly comprises a bag of polymeric film. Scientific evidence of leachates arising from bag film and having a detrimental impact on cell culture growth have been reported and this has resulted in an increased focus on the characterization of bag films used in cell culture systems. The extractables profiles of polymeric films are influenced by a number of factors. In addition to stabilization and processing additives, manufacturing conditions such as polymer extrusion conditions and sterilization conditions also affect the extractables profile.
GE Healthcare has researched whether extractables can be effectively controlled through implementation of risk management from raw material selection to product manufacturing.
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