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Pyrogenicity

Advancing Non-Animal Pyrogens and Endotoxins Testing


Description

Welcome to the NURA course Advancing Non-Animal Pyrogens and Endotoxins Testing.


The global landscape of pyrogens testing is changing rapidly! Join us to learn how you can use the latest in vitro methods for assessment of pyrogenicity for pharmaceuticals and medical devices. Learn from industry experts and the Center for Devices and Radiological Health on how to use non-animal test methods for pyrogens and endotoxins, including Monocyte Activation Test methods and recombinant Bacterial Endotoxins Tests.


Speakers:

Jessica Ponder, PhD, (formerly) Physicians Committee for Responsible Medicine, Moderator

Thomas Hartung, MD, PhD, Centers for Alternatives to Animal Testing (CAAT)

Ruth Daniels, PhD, Janssen

Molly Ghosh, PhD, Center for Devices and Radiological Health (CDRH), US Food and Drug Administration (FDA)

Bernhard Illes, PhD, Microcoat Biotechnologie

Carmen Marin, MS, Roche

Marine Marius, MSc, Sanofi


The videos in this course are available with English and Spanish subtitles. To access these, select the "Settings" (gear) icon within the video.

Content
  • Section 1: Intro to Pyrogens
  • 1.1 Intro to Monocyte Activation Test
  • 1.2 Analytical performance validation of an in-house GMP MAT method
  • 1.3 The new strategy of the European Pharmacopeia on pyrogenicity
  • 1.4 Considerations for Qualification of MAT methods
  • Section 1 Q&A: Pyrogens Test
  • Section 2: Introduction to Endotoxins
  • 2.1 Experiences of a contract laboratory - LAL vs. rFC
  • 2.2 Method Validation Strategy for rFC in Adherence to 3Rs
  • 2.3 Recombinant factor C: from evaluation to implementation
  • Section 2 Q&A: Endotoxins
  • Course Survey
Completion rules
  • All units must be completed
  • Leads to a certificate with a duration: Forever
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