Worst-Case Analysis of Cell Growth in SUS
Single-use technologies are widely used in the bioprocessing industry as they bring a number of advantages over traditional stainless steel solutions.
Increasingly, these technologies are being used in more critical process steps. Yet biopharmaceutical manufacturers have raised concerns about their application and the risk that toxic or inhibitory substances could be released from the materials used for their construction. One solution could be to analyze the potential for cell growth inhibition using a worst- case analysis method.
With this in mind, a team of researchers conducted a study to demonstrate the relationship between results from cell growth tests and the concentration of extracted compounds as quantified by HPLC-UV and LC-MS. The extractable data is focused on the compound bis(2,4-di-tert-butylphenyl)phosphate (bDtBPP,), which is formed when an antioxidant used in polyethylene based single-use containers degrades. Antioxidants are necessary, however, to keep film properties stable, and cannot be easily removed.