Low Endotoxin Recovery/Masking

Low Endotoxin Recovery/Masking

Munich/Bernried, Germany

Course No 15888


Costs

This conference already took place.

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Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

Dr. Ingo Ciolkowski, Lonza AG

John Dubczak, General Manager at Charles River

Stefan Gärtner, L+S AG

Dr Holger Grallert, Hyglos GmbH

Thomas Potrawfke, Haemochrom Diagnostica

Johannes Reich, University of Regensburg

Dr Friedrich von Wintzingerode, Roche Diagnostics GmbH

Objectives

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

Background

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.

Target Group

  • Laboratory management and staff of pharmaceutical microbiology
  • Microbiologists and laboratory assistants from contract laboratories
  • Scientific staff from the area Endotoxin testing

Programme

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
  • Postitive Product Control (PPC)
  • Test inhibition
  • Test enhancement
Endotoxin Recovery Studies for the Detection of Endotoxin Masking Effects
  • 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
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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