Next Steps in Pyrogen Testing: Innovation, Regulation & Reality
Next Steps in Pyrogen Testing: Innovation, Regulation & Reality
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Next Steps in Pyrogen Testing: Innovation, Regulation & Reality
FUJIFILM Biosciences has invited key opinion leaders in pyrogen testing, along with solution providers, to discuss the next steps in this new era of pyrogen testing. This event will feature:
- Insights from Pyrogen Technical Specialists: Learn about current pyrogen and endotoxin testing needs and the full range of detection solutions offered by FUJIFILM Biosciences and partners
- Overviews of available technologies: Explore different reader options for quantitative testing and partner-developed technologies
- Key opinion leader perspectives: Hear from experts involved in the evolution of endotoxin detection methods and their views on validation requirements for new technologies
- New innovations from FUJIFILM Biosciences: Discover the latest tests, methods, and instruments
Limited seating available – maximum capacity 50 attendees (seated). Attendees are welcome to join or leave at any time during the event.
Date: Tuesday, August 26, 2025
Time: 9:00 AM - 3:30 PM
Location: FUJIFILM Cambridge Collaboration Center, One Kendall Square, Building 400, Cambridge, MA 02139
Speakers:
- Karen McCullough, Managing Member, MMI Associates, LLC
- Jenna Bowen, Senior Executive Officer, Cotton Mouton Diagnostics Ltd
- Cathy Olson, Tim Bolus, Molecular Devices, LLC
- Michiyo Nakamura, Hiroki Fukuchi, Tomohisa Nanao, QC Product Development Department, FUJIFILM Wako Chemicals Japan
- Timothy Francis, Delaney Novak, Technical Specialists, FUJIFILM Biosciences
The development team will also be available to answer any questions. We look forward to seeing you there.
Agenda
| 9:00 AM - 9:45 AM | Session 1: Introduction to the FUJIFILM Bioscience Endotoxin and Pyrogen Detection Products |
| 9:45 AM - 10:30 AM | Session 2: Video discussion with the product development team on new methods of pyrogen testing. Challenges and innovation in manufacturing. |
| 10:30 AM - 11:00 AM | Networking / Coffee Break |
| 11:00 AM - 11:45 AM | Session 3: Interview with Karen McCullough: Considerations for the new generation of pyrogen and endotoxin testing products in light of the history of pyrogen and endotoxin testing. |
| 11:45 AM - 12:30 PM | Session 4: Validation of PYROSTAR Neo+/History of USP <85>: Determining the new generation Pyrogen test method for testing needs; Validation of LumiMAT pyrogen testing method. |
| 12:30 PM - 1:15 PM | Lunch break / Instrument Demonstrations / Games and Prizes |
| 1:15 PM - 2:00 PM | Session 5: FUJIFILM bacterial endotoxin assays on SpectraMax readers, including instrument and software demonstration. |
| 2:00 PM - 2:45 PM | Session 6: Keynote Session: History of CMD, and discussion of the aBET Bacterial Endotoxin rapid detection system and applicable methods. |
| 2:45 PM - 3:30 PM | Product Catalog Overview / Follow Up Questions |