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Holistic Extractables and Leachables Program: Evaluations of Prefilled Syringe Systems for Biotechnology Products

Michael Ronk1, Jian Liu2, Alejandra Gallegos2

  • 1Attribute Sciences, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320; mronk@amgen.com snashed@amgen.com.

PDA Journal of Pharmaceutical Science and Technology
|July 18, 2020
PubMed

Keywords:
Delivery deviceExtractablesICH Q3DLeachablesPrefilled syringe

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