Participants of the “Monocyte Activation Test Laboratory Training ” on 20/21 March 2025 in Bernried get a 200 € Discount.
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
These are the questions pharmaceutical microbiologists as well as those responsible for the release have to deal with.
Target Group
- 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.
After the event, you will automatically receive your certificate of participation.
Programme
Seminar Programme as PDF
- Definition of Endotoxins
- Basic reaction of Limulus-based detection Methods
- General LAL-based detection methods
- Construction and interpretation of standard curve
- General rFC-based detection Methods
- Sample handling
- Interpretation of results
- Positive Product Control (PPC)
- Test inhibition
- Experiences with Interferences
- Test enhancement
- Endotoxin masking
- Planning and implementation of hold-time studies
- Interpretation of hold-time studies
- Endotoxin masking
- Planning and implementation of hold-time studies
- Interpretation of hold-time studies
- Mechanistic principles of masking
- Mechanistic principles of demasking
- General mitigation approaches
- Development of dedicated mitigation protocols to overcome LER
- Case Studies
- The ENDO-RS technology for endotoxin demasking
- Demasking protocol development - a case study
- Application of demasking protocols
- Demasking as sample treatment to overcome LER effect
- Validation of a rFC based method
- Combination of demasking and rFC as release test for DP
- Preparation of samples affected by
- Test interference
- Sample interference
- Application of different detection Systems
- Limulus Amebocyte Lysate Assay
- Recombinant Factor C Assay
- Screening for demasking protocol
- Optimization of demasking protocol
- Evaluation of demasking protocol
- Differentiation between test and sample interference
- Effects of different detection systems
- Demasking of endotoxin
This course is part of the GMP Certification Programme "ECA Certified Microbiological Laboratory Manager" Learn more
This training/webinar cannot be booked. Send us your inquiry by using the following contact form.
To find alternative dates for this training/webinar or similar events please see the complete list of all events.
For many training courses and webinars, there are also recordings you can order and watch any time. Just take a look at the complete list of all recordings.
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Please contact us:
Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org
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Seminar Programme as PDF
