April 18–19, 2018Boston Convention & Exhibition CenterBoston, MA

BIOMEDevice Boston 2018 Schedule Viewer

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Advanced Methods for Identification and Quantification of Leachables from Components Used in Manufacturing Pharmaceuticals


James Woods (Senior Research Scientist, Jordi Labs)

Location: Tech Theater, Booth 155

Date: Wednesday, April 18

Time: 12:30pm - 1:15pm

Pass Type: Conference (Paid), Expo (Free) - Get your pass now!

Free Content & Activities: Tech Theater

Vault Recording: TBD

The identification of Extractables and Leachables (E&L’s) requires screening extracts for components of wide chemical diversity. E&L’s have highly varied properties including widely ranging polarity, volatility and molecular weight which creates difficulty in identification and quantification. Identification of leachables in complex matricesis made even more difficult by the fact that many of these matrices, such as drug products, cell culture media, or biological simulants contain significant levels of background interferences. These interferences can suppress ionization, necessitate sample work up prior to analysis, and cause other analytical challenges. If ignored, these factors can often conceal signals from individual leachables. In this presentation, we will demonstrate the effect of changes in sample work up prior to instrumental analysis on the number and type of leachable compounds identified from a component used in the manufacturing of a biopharmaceutical following guidance from USP 1663, 1664 and the draft guidance from USP 665. Methodologies for transfer of leachable compounds to solvents amenable to GCMS and LCMS analysis, such as liquid-liquid extraction, solvent exchange and direct injection will be compared. An advanced method of data reduction will be demonstrated comparing the use of differential analysis software to manual data reduction in a complex leachables matrix. The effects of complex matrices on formal quantification will also be presented, highlighting the achievable limits of detection and quantification using QqQ instrumentation. Comparison of the concentration values determined through estimation via relative quantification and formal quantification will also be presented.