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Updated Lab Testing Methods to Safeguard Global Health eBook

This ebook is intended to help educate readers about the importance of rapid, quality testing for extractables and leachables (E&L) to ensure cGMP compliance and, most importantly, patient safety. Inside this ebook you can learn more about trends in the biopharmaceutical market, concerns of toxic-related impurities, and recent guidance by the US FDA that can be useful in planning the proper framework to assess drug products and ensure timely delivery to market and optimization of patient health around the globe.

The contents are as follows:

  • Why Extractables & Leachables Matter
  • Testing of Packaging Systems for Large-Volume Parenteral Drugs: Extractables Study Design and Challenges
  • Rapid Sterility Testing: A New Solution for Short Shelf-Life Products
  • The Necessity of Extractable and Leachable Qualifications for Lyophilized Drug Products: Some Fallacies Addressed

Learn more about the authors below.

Piet Christiaens, PhD

Piet Christiaens, PhD

Scientific Director, E&L Expert

Piet Christiaens received his Ph.D. from the Analytical Chemistry Department of the University of Leuven (Belgium) in 1991. From 1992 to 1997, he was Lab Manager in two CROs. From 1997 to 2000, he worked as an independent consultant with Shell Chemical Company in Houston, Texas (US), working on hydrogenated triblock co-polymers. Since 2001, Piet...

Karen Pieters

Karen Pieters

Large Volume Parenterals, Ophthalmics, and Disposables
Senior E&L Expert

Karen Pieters graduated as a bioengineer in chemistry in 2006. Karen joined Nelson Labs Europe in 2010 as a Study Director for different applications. She now leads a team of study directors with a focus on Large Volume Parenterals, Ophthalmics, and Disposables. She has presented on the set-up and challenges of extractables and leachables studies...

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