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?
Programme
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
Further Information
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.
Testimonials
