Participants of the “Low Endotoxin Recovery Laboratory Training Course” on 18/19 March 2025 in Bernried get a € 200 Discount.
Objectives
Background
Some of the reasons are:
- Animal experiments have to be reduced. Especially with the current EU Regulations.
- Reduction of variance by validatable in-vitro test Methods.
- Get an alternative Test, where the classic LAL shows some gaps, e.g. Contamination of biologicals by non-endotoxin pyrogens not detectable in LAL test is not unlikely.
Following, with continuous support by the German Pharmacopoeia, the EDQM MAT Expert group was re-established and finally the MAT Monograph 2.6.30. was implemented into the European Pharmacopoeia in 2010. Meanwhile, the EDQM performed a MAT-survey to improve the MAT monograph and the BET-Guideline 5.1.10. and the Rabbit Pyrogen Test (RPT) monograph, 2.6.8. have been revised to clarify the priorisation of the MAT compared to the RPT (especially in regards to the EU directive 2010/63). However, there are still open questions how MAT can be applied in a routine lab for release testing. The meeting will give guidance for proper use of MAT and strengths and weaknesses will be discussed.
Target Group
- pharmaceutical manufacturers
- biopharmaceutical companies
- medical device manufacturers
- contract laboratories
- tissue establishments
- authorities
Date / Venue / Presentations / Certificate
Thursday, 20 March 2025, 09.00 – 17.15 h
(Registration and coffee 08.30 – 09.00 h)
Friday, 21 March 2025, 08.45 – 16.15 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 19 March at appr. 19.00 h from Munich Airport to Hotel Seeblick.
On 21 March at appr. 16.30 h from Microcoat to Munich Airport.
After the event, you will automatically receive your certificate of participation.
Programme
Seminar Programme as PDF
- What are pyrogens?
- Diversity of pyrogens
- Activation of the human immune system through TLRs stimulation
- Detection of cytokines using the MAT
- Explanation of European Pharmacopoeia 2.6.30
- International status of MAT
- Experimental set-up and preparation of samples (e.g., stimulation of cells)
- Loading of cells on assay plate
- History of the Rabbit Pyrogen Test
- Pharmacopoeial requirements
- Regulatory requirements and animal welfare (EU-Directive 2010/63/EU)
- Field of application
- Future of pyrogene detection
- Vendors of MAT
- Composition of the different MATs
- Specifity/Sensitivity
- Measurement of Samples
- Intro to Vaccines and Pyrogens – Choice of method
- MAT development for vaccines containing inherent pyrogen components
- Case Study 1: Characterization of the absence of NEP
- Case Study 2 : Consistensy of production in the case of product containing intrinsic pyrogen
- Current regulatory perspectives
- Selection of Monocytes
- Read-out of Cytokines
- Methods
- Development of MAT method
- Generic method Validation
- Product-specific validation
- Release testing
- Presentation of the laboratory results
- Discussion of the results
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
