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
- 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