Sprecher
Dr Friedrich von Wintzingerode
Roche Diagnostics GmbH
Stefan Gärtner
L+S AG
Dr Saskia Ihle
Lonza
Johannes Reich
University of Regensburg
Dr Holger Grallert
Hyglos GmbH
Thomas Potrawfke
Haemochrom Diagnostica
Marion Usedom
Charles River Laboratories
Zielsetzung
How to identify Low Endotoxin Recovery (LER)
How to Set-up hold-time studies
Analysis of influencing factors (Sample matrices, endotoxin, temperature, detection methods, etc.)
Understanding the driving forces of LER
Interpretation of test results
Dedicated sample treatment for demasking
Hintergrund
In the last years the LAL test has become the preferred system to test for endotoxins – for the in-process control as well as in the final inspection – and it is anchored in the pharmacopoeias. However, in the recent past, the problem of low endotoxin recovery employs the pharmaceutical microbiology. Masking – or not? Evidence gaps? And how can I close them? And how to evaluate?
These are the questions the pharmaceutical microbiologists as well as those responsible for the release have to deal with.
And last but not least, how can we handle the test in daily business in a practical manner.
Zielgruppe
Laboratory management and staff of pharmaceutical microbiology
Microbiologists and laboratory assistants from contract laboratories
Scientific staff from the area Endotoxin testing
Programm
Endotoxin Detection Methods I
Definition of Endotoxins
Nature of Endotoxin
General detection methods
Thomas Potrawfke, Haemochrom Diagnostica
Endotoxin Detection Methods II
Basic reaction of Limulus-based detection methods
Sample handling
Construction and interpretation of standard curve
Dr Saskia Ihle, Lonza
Utilizing high speed atomic force microscopy (HSAFM) to observe the conformational changes and stability of LPS, in the presence of detergents, and its impact on biological activity and LER. Mechanisms of LER can be influenced by LPS stability
Varying size and fragility of LPS aggregates can be directly correlated to presence of chelating agents and detergents
Elucidating conformational changes, in real time, on LPS using HSAFM
Marion Usedom, CRL
Test Interference
Postitive Product Control (PPC)
Test inhibition
Test enhancement
Stefan Gärtner, L+S
Sample Interference (LER)
Endotoxin Masking
Planning and implementation of hold-time studies
Interpretation of hold-time studies
Dr Friedrich von Wintzingerode, Roche Diagnostics GmbH
Demasking of Endotoxin
Mechanistic principles of demasking
Development of demasking protocols
Implementation of demasking protocols
Johannes Reich, University Regensburg
Sample Preparation for Demasking
Practical demasking procedure
Preparation of reagents for demasking
Application of demasking protocols
Dr Holger Grallert, Hyglos
Round Table Discussion
Practical Laboratory Work:
(Microcoat GmbH)
Simulation of contamination in various sample
matrices
Preparation of samples affected by
Test interference
Sample interference
Endotoxin Service Team, Microcoat GmbH
Analysis of interference in affected samples
Application of different detection systems
Limulus Amebocyte Lysate assay
Recombinant Factor C assay
Endotoxin Service Team, Microcoat GmbH
Sample treatment for demasking
Screening for demasking protocol
Optimization of demasking protocol
Evaluation of demasking protocol
Endotoxin Service Team, Microcoat GmbH
Interpretation and Comparison of Results
Differentiation between test and sample interference
Effects of different detection systems
Demasking of endotoxin
Endotoxin Service Team, Microcoat GmbH
Closing Remarks (ECA Academy)
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