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)
- Positive Product Control (PPC)
- Test inhibition
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
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