Low Endotoxin Recovery/Masking
Hands-on Laboratory Training Course
Im Auftrag der ECA Academy

11/12 February 2020

Bernried, Germany

Seminar Nr. 17424

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Tel.: 06221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Sprecher

John Dubczak, Charles River Laboratories
Stefan Gärtner, Labor LS
Dr Holger Grallert,Hyglos
Dr Andreas Karst,Haemochrom Diagnostica
Dr Johannes Reich,Microcoat Biotechnologie
Kevin Williams, bioMérieux
Veronika Wills,ACC
Dr Thomas Winkler, Lonza Cologne

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 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 Endotoxin testing area

Programm

Endotoxin Detection Methods I

Definition of Endotoxins
Nature of Endotoxin
General detection methods

Endotoxin Detection Methods II

Basic reaction of Limulus-based detection methods
Sample handling
Construction and interpretation of standard curve

LER: Reflecting on Biopharmaceutical Operational Reality

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

Test Interference I (Inhibition)

Positive Product Control (PPC)
Test inhibition
Test enhancement

Test Interference II (Enhancement)

Experiences with Interferences
Test enhancement

Technical Report - Guidance for LER Hold time studies

Endotoxin Masking
Planning and implementation of hold-time studies
Interpretation of hold-time studies

Demasking of Endotoxin

Mechanistic principles of demasking
Development of demasking protocols
Implementation of demasking protocols

Sample Preparation for Demasking

Practical demasking procedure
Preparation of reagents for demasking
Application of demasking protocols

Misconceptions in LAL/rFC testing

Masking
rFC/LAL specificity
LAL and beta-glucans
Compendial update of rFC

Practical Laboratory Work

Simulation of Contamination in Various Sample Matrices

Preparation of samples affected by
Test interference
Sample interference

Analysis of Interference in Affected Samples

Application of different detection systems
Limulus Amebocyte Lysate assay
Recombinant Factor C assay

Sample Treatment for Demasking

Screening for demasking protocol
Optimization of demasking protocol
Evaluation of demasking protocol

Interpretation and Comparison of Results

Differentiation between test and sample interference
Effects of different detection systems
Demasking of endotoxin

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Low Endotoxin Recovery/MaskingHands-on Laboratory Training CourseIm Auftrag der ECA Academy