Dr Holger Kavermann
Roche Diagnostics
Referent:innen
Participants of the “Monocyte Activation Test Laboratory Training ” on 20/21 March 2025 in Bernried get a 200 € Discount.
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.
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
Date / Venue / Presentations / Certificate
Tuesday, 18 March 2025, 09.30 – 17.15 h
(Registration and coffee 09.00 – 09.30 h)
Wednesday, 19 March 2025, 08.30 – 17.00 h
Overnight Stay
Hotel Seeblick
Tutzinger Straße 9
82347 Bernried am Starnberger See, Germany
Phone +49 (0) 8158 / 254 – 0
Email info@seeblick-bernried.de
Venue of the Laboratory Course
Microcoat Biotechnologie GmbH
Am Neuland 3
82347 Bernried am Starnberger See, Germany
Transfer service from Hotel Seeblick to Microcoat in the morning and back in the evening will be organised.
Shuttle Service from/to Munich Airport: On 17 March at appr. 19.00 h from Munich Airport to Hotel Seeblick.
On 19 March at appr. 17.15 h from Microcoat to Munich Airport.
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.
After the event, you will automatically receive your certificate of participation.
Programm
Gesamtes Programm als PDF herunterladen
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
Dieses Seminar/Webinar kann nicht gebucht werden. Alternative Termine für dieses Seminar/Webinar und ähnliche Veranstaltungen finden Sie in der Übersicht nach Thema..
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This course is part of the GMP Certification Programme "ECA Certified Microbiological Laboratory Manager"
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E-Mail: info@concept-heidelberg.de
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Seminarprogramm als PDF
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