Dr Christian Faderl
bioMérieux Deutschland
Referent:innen
Dr Holger Kavermann
Roche Diagnostics
Dr Michael Kracklauer
Microcoat Biotechnologie
Alessandro Pauletto
BioMerieux Italy
Marc Zechmann
MicroCoat
Veronika Wills
Associates of Cape Cod
Luis Barthelmes
Labor LS
Georg Schumm
Lonza Cologne
Participants of the “Monocyte Activation Test Laboratory Training ” on 12/13 March 2026 in Bernried get a 200 € Discount.
Zielgruppe
- Laboratory management and staff of pharmaceutical microbiology
- Microbiologists and laboratory assistants from contract laboratories
- Scientific staff from the Endotoxin testing area
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
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?
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?
Programm
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 and Enhancment)
- Positive Product Control (PPC)
- Test inhibition
Test Interference II [Enhancement and Specific Detection (β-Glucans)]
- 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
Weitere Informationen
Overnight Stay
Hotel Seeblick
Tutzinger Straße 9
82347 Bernried am Starnberger See, Germany
Phone +49 (0) 8158 / 254 – 0
Email info@seeblick-bernried.de
Accommodation
CONCEPT HEIDELBERG has reserved a limited number of rooms in the Hotel Seeblick. You will receive a room reservation form/POG when you have registered for the conference. Reservation should be made directly with the hotel. Early reservation is recommended.
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 09 March at appr. 19.00 h from Munich Airport to Hotel Seeblick. On 11 March at appr. 17.15 h from Microcoat to Munich Airport.
Fees (per delegate, plus VAT)
ECA Members € 1,990
APIC Members € 2,090
Non-ECA Members € 2,190
EU GMP Inspectorates € 1,095
The fee is payable in advance after receipt of invoice and includes dinner on the first day, lunch on all three days, and all refreshments. VAT is reclaimable.
Social Event
On the evening of the first course day, the participants are cordially invited to a dinner. This event is an excellent opportunity to share your experiences with colleagues from other companies in a relaxed atmosphere.
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.
Conference language
The official conference language will be English.
Contacts
Questions regarding content:
Mr Axel H. Schroeder, +49 6221 84 44 10, schroeder@concept-heidelberg.de
Questions regarding organisation:
Ms Isabell Helm, +49 6221 84 44 49, helm@concept-heidelberg.de
Datum & Uhrzeiten
Tuesday, 10 March 2026, 09.30 – 17.15 h
(Registration/coffee 09.00 – 09.30 h)
Wednesday, 11 March 2026, 08.30 – 17.00 h
(Registration/coffee 09.00 – 09.30 h)
Wednesday, 11 March 2026, 08.30 – 17.00 h
Teilnahmegebühr
| ECA-Member*: | € 1990,- |
| Non ECA Member*: | € 2190,- |
| EU/GMP Inspectorates*: | € 1095,- |
| APIC Member Discount*: | € 2090,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Aufzeichnung/weitere Termine nicht verfügbar
Aufzeichnung/weitere Termine nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Microbiological Laboratory Manager"
Haben Sie noch Fragen?
Wir stehen Ihnen für weitere Auskünfte gerne zur Verfügung.
E-Mail: info@concept-heidelberg.de
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