SOURCE: Xtalks

Xtalks Webinars

November 07, 2014 07:05 ET

Extractable and Leachable Compounds: The Importance of Having Unique Identifications and Its Impact on Toxicological Risk Evaluation, Live Webinar Hosted by Xtalks

TORONTO, ON--(Marketwired - November 07, 2014) - The webinar will argue that it is time for the industry to move beyond this mind-set. Not only do the electronic media match the capabilities of paper, but there are capabilities unique to electronic media which allow data capture to be engineered in ways that are not possible using pen and paper. The live broadcast will take place on Tuesday, November 18, 2014 at 11am EST (4pm GMT).

The importance of extractable/leachable testing for container closure systems (CCS) in the pharmaceutical industry has grown considerably in the last few years, driven by well-documented incidents where impurities in the contained drug product -- introduced by the container closure system via leaching -- were found to be harmful to the patients, as well as an increase in global regulatory requirements associated with such concerns.

As a first step in the qualification of a container or closure from an E/L-perspective, a controlled extraction study must be performed to understand the associated extraction profile of that material. Apart from the technical issues in designing these extractable studies, it is of utmost importance to identify as many compounds as possible during a "First Pass" experiment. This is why Toxikon developed the TOX-RAY Screener Database, which allows to uniquely identify compounds, based upon the analysis of over 3500 actual standards. In addition, Toxikon has invested heavily in the high-end, state-of-the-art analytical techniques to further unravel the structure of some compounds that are not readily identified. These techniques can significantly contribute to further determine the chemical structure of a molecule.

Knowing the structure of a chemical compound is of high importance, even at the level of an extraction study, because it's the chemical structure (a.o.) that will determine its toxicity. Toxikon developed a unique tool, called TOX-RITE (Rapid Initial Toxicological Evaluation) to allow a quick toxicological screening of the analytical results of an extraction study. This allows to rapidly identify which compounds should be monitored during the subsequent "formal" leachable study.

Join the panel from Toxikon Corporation including John Iannone, Program Manager for Extractables/Leachables & Special Studies, Karen Pieters, Project Manager for Extractables/Leachables, and Anja Cerstiaens, Study Director Coordinator, as they examine some key topics:

  • Introduction -- Regulatory Aspects
  • Designing an Extractable & Leachable Study
  • Tools to assist in Unique Identifications: Toxikon's TOX-RAY Screener Database
  • High-End Analytical Techniques, used by Toxikon, which can contribute to further unravel the Structure of a Molecule
  • The Importance of having a Chemical Structure for subsequent toxicological evaluations
  • Toxikon's TOX-RITE approach to Rapid Initial Toxicological Evaluations for Extractable Studies

To learn more about this event visit: Extractable and Leachable Compounds: The Importance of Having Unique Identifications and its Impact on Toxicological Risk Evaluation.

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global Life Sciences community. Every year thousands of industry practitioners (from pharmaceutical & biotech companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

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