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Whitepaper

WHITEPAPER

The Necessity of Extractable and Leachable Qualifications for Lyophilized Drug Products: Some Fallacies Addressed

Understand the need to perform extractable and leachable evaluations for lyophilized drug products from a scientific perspective.

Lyophilized drug product containers and administration devices consist of the primary packaging (typically a glass vial and a rubber stopper), the reconstitution solution container (typically a vial or a prefilled syringe system), and the drug administration set (such as a disposable syringe, an intravenous bag, or a pump system with administration tubing) as shown in the Whitepaper.

 

Piet Christiaens

Piet Christiaens

PhD
Scientific Director

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...

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