*CMC QC Workshop* by ACROBiosystems hosted by Cellcolab.
CMC QC Workshop by ACROBiosystems hosted by Cellcolab.
Join ACROBiosystems in Hamburg for a one-day technical workshop on microbial testing in biopharmaceutical quality control. Explore endotoxin testing, rapid mycoplasma and sterility detection, and hands-on recombinant Factor C assay practice. Lunch will be provided.
09:30–09:45
Check-in
Arrive from 09:30 for registration.
09:45–10:00
Welcome Speech
The workshop begins with a welcome and introduction to the day's program.
10:00–10:45
Endotoxin Testing: Status and Trends
Review the status and trends of endotoxin testing, including regulations, methods, and application challenges.
10:45–11:00
Break
11:00–11:30
“The landscape of animal free endotoxin and non-endotoxin pyrogen testing.” Dr Bettina Katterle – Head of Sales Germany, Eurofins BioPharma Product Testing
The talk will give you an overview of the rapidly evolving landscape of animal-free pyrogen and endotoxin testing following the European Pharmacopoeia transition away from the Rabbit Pyrogen Test.
We will examine the scientific principles, regulatory drivers, capabilities of modern in vitro technologies. This includes the Monocyte Activation Test (MAT) and the now compendial Recombinant Factor C (rFC) as alternative to the LAL test.
Let´s discuss how these methods support compliant testing strategies for today's pharmaceutical and biopharmaceutical products, backed up data from our case studies.
11:30–12:30
Lunch break
12:30–13:30
Recombinant Factor C Endotoxin Detection assay: Procedure overview
Review the key steps and operational considerations of the Recombinant Factor C Endotoxin Detection assay in preparation for the hands-on laboratory session.
13:30–15:30
Hands-on laboratory practice
Work through a guided laboratory session focused on practical QC testing.
15:30–15:45
Break
15:45–16:15
Rapid mycoplasma and sterility detection
Explore rapid detection technologies, regulatory requirements, testing methodologies, application scenarios, and practical challenges and solutions.
16:15–17:00
Q&A and wrap-up
Bring your questions for an open discussion and a summary of the day's key takeaways.