*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.
Title: Regulatory Updates Driving Advances in Endotoxin Testing and Compliance Practices
Session Overview: As pharmacopeial requirements evolve, biopharmaceutical companies have new options in endotoxin testing, from method selection and technology upgrades to regulatory compliance.
This session will highlight the revision of Ph. Eur. general chapter 2.6.14, Bacterial Endotoxins, introducing the Recombinant Factor C (rFC) fluorimetric end-point method (Method G), effective January 1, 2027. Key topics include method validation, technology transfer, and compliance considerations.
Through practical case studies and hands-on experience, we will explore how to implement updated testing methods, optimize endotoxin testing strategies, and meet evolving regulatory requirements.
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.
Title：Rapid Mycoplasma and Sterility Testing: Accelerating Quality Control and Product Release
Session Overview: Traditional mycoplasma and sterility testing methods often involve lengthy testing timelines, creating challenges for biopharmaceutical manufacturing, particularly for products with short shelf lives. This session will explore advances in rapid microbiological testing, from the limitations of conventional methods to the principles and practical applications of emerging technologies.
We will also highlight key regulatory developments, including the revised Ph. Eur. chapter 2.6.7 (12.2) on mycoplasma testing and the growing recognition of rapid sterility testing approaches under chapter 2.6.1.
Through practical application insights, we will discuss how rapid testing technologies can help shorten testing timelines, support timely product release, and improve manufacturing efficiency while maintaining quality and regulatory compliance.
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.