Identification of unknown extractables and leachables using mass spectrometry: Identification with confidence?


21st November 2019 | 10.00 am EST | Petra Booij, Investigator at GlaxoSmithKline |BOOK FREE SEAT

Extractable and Leachable (E&L) studies on materials used in the manufacturing process and container closer systems of drug products and drug substances are commonly used to assess the risk for patient exposure. Most often LC-MS or GC-MS is used to detect, identify and then quantify extractables and leachables. In general, an analytical evaluation threshold or reporting threshold is set based on a calculated patient exposure. Substances above the set threshold required further investigation if patient exposure exceeds this. Substances can be identified using mass spectral libraries to enable a toxicological risk assessment which considers the risk of patient exposure. However, how confident are we when we identify a substance using spectral libraries? A match with mass spectral libraries, data from orthogonal techniques, fragmentation data and availability of a certified reference standard can increase the level of confirmation. We will discuss an approach for different levels of identification and how to increase the level of confidence of identified extractables and leachables.

Presented by Petra Booij, Investigator at GlaxoSmithKline

Petra obtained a PhD in analytical chemistry from the VU University in Amsterdam, The Netherlands. She is currently working in GSKs E&L team based in Stevenage (UK). Her work focusses on trace level analysis, identification and confirmation of E&L using mass spectrometry, and risk assessments of E&L within biopharma and cell and gene therapy. She is a member of the ELSIE leachable team and involved in harmonising approaches for leachable testing.


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