Low Endotoxin Recovery/Masking - Hands-on Laboratory Training Course

5/6 March 2024, Bernried, Germany

Course No. 21193

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Speakers

Dr. Holger Kavermann

Dr. Holger Kavermann

Roche Diagnostics

Dr. Bernhard Illes

Dr. Bernhard Illes

MicroCoat

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 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 Endotoxin testing area

Presentations / Certificate

The presentations for this event will be available for you to download and print before and after the event. Please note that no printed materials will be handed out on site and that there will not be any opportunity to print the presentations on site. After the event, you will automatically receive your certificate of participation.

Programme

Low Endotoxin Recovery/Masking - Hands-on Laboratory Training Course

Seminar Programme as PDF

Endotoxin Detection Methods I (Focus on LAL)
  • Definition of Endotoxins
  • Basic reaction of Limulus-based detection methods
  • General LAL-based detection methods
  • Construction and interpretation of standard curve
Endotoxin Detection Methods II (Focus on rFC)
  • General rFC-based detection Methods
  • Sample handling
  • Interpretation of results
Test Interference I (Inhibition)
  • Positive Product Control (PPC)
  • Test inhibition
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
Sample Interference/Hold Time Case Studies
  • Endotoxin Masking
  • Planning and implementation of hold-time studies
  • Interpretation of hold-time studies
Mechanistic Principles of Endotoxin Masking and Demasking
  • Mechanistic principles of masking
  • Mechanistic principles of demasking
Mitigation of LER - General Approach
  • General mitigation approaches
  • Development of dedicated mitigation protocols to overcome LER
  • Case Studies
Sample Preparation to Reverse the LER Effect
  • The ENDO-RS technology for endotoxin demasking
  • Demasking protocol development - a case study
  • Application of demasking protocols
Validation of Demasking Method using rFC-based Assay
  • Demasking as sample treatment to overcome LER effect
  • Validation of a rFC based method
  • Combination of demasking and rFC as release test for DP

Practical Laboratory Work at Microcoat
 
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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This course is part of the GMP Certification Programme "ECA Certified Microbiological Laboratory Manager" Learn more

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E-Mail: info@gmp-compliance.org

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