Low Endotoxin Recovery/Masking
Hands-on Laboratory Training Course
Im Auftrag der ECA Academy
Bernried, Germany
Seminar Nr. 17424
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Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail: info@concept-heidelberg.de
Sprecher
John Dubczak, Charles River Laboratories
Stefan Gärtner, Labor LS
Dr Holger Grallert,Hyglos
Dr Andreas Karst,Haemochrom Diagnostica
Dr Johannes Reich,Microcoat Biotechnologie
Kevin Williams, bioMérieux
Veronika Wills,ACC
Dr Thomas Winkler, Lonza Cologne
Stefan Gärtner, Labor LS
Dr Holger Grallert,Hyglos
Dr Andreas Karst,Haemochrom Diagnostica
Dr Johannes Reich,Microcoat Biotechnologie
Kevin Williams, bioMérieux
Veronika Wills,ACC
Dr Thomas Winkler, Lonza Cologne
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.
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?
Zielgruppe
- Laboratory management and staff of pharmaceutical microbiology
- Microbiologists and laboratory assistants from contract laboratories
- Scientific staff from the Endotoxin testing area
Programm
Endotoxin Detection Methods I
- Definition of Endotoxins
- Nature of Endotoxin
- General detection methods
Endotoxin Detection Methods II
- Basic reaction of Limulus-based detection methods
- Sample handling
- Construction and interpretation of standard curve
LER: Reflecting on Biopharmaceutical Operational Reality
- Mechanisms of LER can be influenced by LPS stability
- Varying size and fragility of LPS aggregates can be directly correlated to presence of chelating agents and detergents
- Elucidating conformational changes, in real time, on LPS using HSAFM
Test Interference I (Inhibition)
- Positive Product Control (PPC)
- Test inhibition
- Test enhancement
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
Demasking of Endotoxin
- Mechanistic principles of demasking
- Development of demasking protocols
- Implementation of demasking protocols
Sample Preparation for Demasking
- Practical demasking procedure
- Preparation of reagents for demasking
- Application of demasking protocols
Misconceptions in LAL/rFC testing
- Masking
- rFC/LAL specificity
- LAL and beta-glucans
- Compendial update of rFC
Practical Laboratory Work
Simulation of Contamination in Various Sample Matrices
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
GMP Seminare nach Thema
- Allgemeine QA Themen + GMP Compliance
- Regulatory Affairs
- Development
- Datenintegrität
- Analytik allgemein
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- Computervalidierung
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- Pharma Engineering allgemein
- API/Wirkststoffe/Hilfsstoffe
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- Sachkundige Person (QP)
- European Conferences and Education Courses
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- Dokumentation
- Reinigungsvalidierung
- IT allgemein
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- OOS / OOT / OOE
- Rohstoff-Prüfung
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- Gerätequalifizierung
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- Allgemeine mikrobiologische Themen
- Mikrobiologische Tests
- Technik
- Herstellung allgemein
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- Phytopharmaka/Cannabis/Radiopharmazeutika