Pharma Science

Extractables and Leachables from Single Use Bioprocess Systems

Biosim_eSem_icon.pngExtractables and leachables (E&Ls) are small molecules present in a polymer system including antioxidants, surfactants, slip agents, plasticizers, acid scavengers, cross linking agents, residual monomers and oligomers, polymerization side products and process impurities. Extractables may not be leachables depending on their solubility and the use conditions of the device.

In this presentation we'll look at some background to E&Ls, an overview of the single use system, the model device used, extraction conditions, qualitative results, mass spectroscopy software tools and method sensitivity.

Separation Science, in collaboration with Agilent Technologies, has developed an eSeminar covering the analysis of biotherapeutics and biosimilars. 

MarkJordi.pngThis presentation is given by Mark Jordi (Jordi Labs, USA)

By attending this presentation you will learn about the process of identifying unknown extractables and leachables, which involves:

  • recursive feature finding to identify unique mass features
  • statistical filtering to remove compounds not unique to the extract
  • abundance filtering to remove those compounds not present at a toxicological level
  • identification using a combination of database searching and molecular formula generation

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