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

30th January 2020 | 10.00 am EST | Petra Booij, Investigator at GlaxoSmithKline and Dr Kyle D’Silva, Pharma & BioPharma Marketing Leader, Thermo Fisher Scientific |WATCH FOR FREE

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.

Sponsored by Thermo Fisher Scientific

Thermo Fisher Scientific is the world leader in serving science, with revenues of more than $24 billion and approximately 70,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics, deliver medicines to market and increase laboratory productivity. Through our premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services – we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive services.

And Dr Kyle D’Silva, Pharma & BioPharma Marketing Leader, Thermo Fisher Scientific

Dr. D’Silva is an analytical chemist who began his career researching human dietary exposure to contaminants using advanced spectrometric techniques for a UK government research and reference laboratory. Dr. D’Silva’s mass spectrometry expertise took him on a career journey through several instrument vendors in applications, product management, product marketing, and vertical marketing roles. Dr. D’Silva now leads the marketing of chromatography and mass spectrometry instrumentation and solutions for pharmaceutical & biopharmaceutical industries. He holds a Bachelor of Science degree in Color Chemistry, a Master of Science degree in Analytical Chemistry and Instrumentation, and a Ph.D. in research involving the application of high-resolution mass spectrometry.

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