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Thermo Fisher Scientific

AN 51921 - Phosphate Salts, Qualitative Identification and Quantitative Contamination Analysis with Near-Infrared Spectroscopy

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This application note resulted from a case study whereby a bioprocessing company was provided subquality raw materials for preparing complex cell culture buffers. These inferior raw materials were undetectable using the standard quality assurance methods and eventually resulted in over $3 million dollars in lost finished product, investigations and recovery as well as a damaged reputation. Further investigation traced the subquality raw material to a batch of poorly refined sodium phosphate dibasic (Na2HPO4). Specifically, the poorly refined material contained significant quantities of pyrophosphate ion (P2O7-4). The presence of this pyrophosphate led to incorrectly formulated synthetic cell culture media, which subsequently damaged, destroyed and invalidated healthy bioreactor runs. Complex analysis using inductively coupled plasma mass spectrometry (ICP-MS) on the finished cell culture media was able to detect the presence of pyrophosphate. Eventually this was traced to the sodium phosphate dibasic raw material. Subsequent NIR analysis proved that the inferior raw materials provided by the vendor would have been quickly and positively identified and quantified at the receiving dock, if the Antaris NIR system had been in place.