Low Endotoxin Recovery/Masking Hands-on Laboratory Training Course

Low Endotoxin Recovery/Masking

Bernried, Germany

Course No 20739

This course is part of the GMP Certification Programme "ECA Certified Microbiological Laboratory Manager". Learn more.

 

Costs

ECA-Member*: EUR 1890,--
Non ECA Member*: EUR 2090,--
EU/GMP Inspectorates*: EUR 1045,--
APIC Member Discount*: EUR 1990,--

(All prices excl. VAT)

* also payable by credit card American Express Visa Mastercard

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

Aoife Barron, Lonza Biologics
Jacqueline Dünisch, Labor L+S
Dr Christian Faderl, bioMérieux Deutschland
Dr Bernhard Illes, Microcoat
Dr Andreas Karst, Haemochrom Diagnostica
Dr Holger Kavermann, Roche
Dr Michael Kracklauer, Microcoat
Veronika Wills, ACC
 

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

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 Intergerences
  • 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
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 reatment for Demasking
  • Screening for demasking protocol
  • Optimization of demasking protocol
  • Evaluation of demasking protocol
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

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