Navigating the Regulatory World of Pyrogen and Endotoxin Testing

Explore how global regulations are shaping the evolving landscape of pyrogen and endotoxin testing beyond traditional LAL assays. This webinar reviews the transition from rabbit pyrogen testing to LAL, recombinant, and synthetic alternatives, with insights into current regulatory and pharmacopeia guidelines.

Register Free: https://www.biopharminternational.com/bp_w/pyrogen

Event Overview:

Since the 1980s, limulus amebocyte lysate (LAL) has served as the gold standard for bacterial endotoxin testing, as detailed in USP Chapter <85>. However, evolving trends and the emergence of sustainable assay alternatives have introduced increasing complexity into the regulatory landscape of pyrogen and endotoxin testing. To gain a clear understanding of the global framework governing these tests, it is essential to examine how individual regulatory agencies and pharmacopeias define their testing requirements. This webinar will provide a comprehensive overview of these guidelines, connecting them to relevant pyrogen and endotoxin testing methodologies. The discussion will trace the historical progression from the rabbit pyrogen test to the LAL assay, and onward to new recombinant and synthetic testing options.

Key Learning Objectives

• Explain the transition from the rabbit pyrogen test (RPT) to bacterial endotoxin testing (BET)
• Introduce “new era” testing methods, including MAT and recombinant BET reagents
• Explain guidelines on BET and pyrogen testing from global pharmacopeial bodies and regulatory agencies

Who Should Attend

• Quality control managers and technicians
• Microbiologists
• Quality assurance managers and technicians
  

Speaker:

Delaney Novak
Associate Field Application Scientist
FUJIFILM Biosciences

Delaney Novak is an associate field application scientist for the pyrogen testing division of FUJIFILM Biosciences. She holds a bachelor of science in environmental science alongside a minor in biology. She enjoys working in a collaborative environment and is always open to addressing new challenges and answering complex questions. She applies these skills to further support any technical needs or concerns you may have in your pyrogen testing endeavors.

Register Free: https://www.biopharminternational.com/bp_w/pyrogen