Endotoxins are powerful and ubiquitous pyrogens, and their parenteral intake, even in small amounts, may cause severe inflammation, sepsis, and even death.1 Moreover, in research settings, endotoxins may lead to erroneous and misleading results. Therefore, endotoxin screening has become a routine step in the manufacturing of parenteral products for the pharmaceutical industry and in a number of research applications.
The Limulus amebocyte lysate (LAL) assay is the best established tool for endotoxin identification and evaluation.2 Its findings play a critical role in the decision on how to proceed with biological and pharmaceutical samples.
However, the routine LAL test does not give you a simultaneous access to the full set of data, and many errors, such as incorrect concentrations or out-of-specification reagents, may go undetected.
Gaining access to the full set of LAL assay data enables you to detect data trends and to identify experimental problems early on. The Toximaster® QC8 software has emerged as a tool that readily and clearly presents the complete set of LAL assay data.
What is the Toximaster® QC8 software?
Toximaster® QC8 is an innovative and reliable software application that enables the data processing of protocols for bacterial endotoxin determination. It is compliant with three pharmacopeia types (the US, European, and Japanese pharmacopeias) as well as with the US Food and Drug Administration (FDA) CFR 21 Part 11 electronic records/electronic signature (ERES). The software is based on a standard workflow that should be reviewed and approved prior to operation and it is to be used with the Toxinometer® tube reader or the ELx808IU microplate reader.
What are the advantages of the Toximaster® QC8 software?
Complete visualization of the activation curve
Toximaster® QC8 defines sample types, such as standards, controls, and test samples, and creates three types of curves (an internal standard curve, a manual input curve, and a measured curve). The software readily detects changes in data trends, and the additional details that it provides enable you to detect arising problems early on and, in many cases, to pinpoint them precisely.
High precision and accuracy
While pharmacopeial standards call for 50%–200% recovery rates, the Toximaster® QC8 software enables much more specific and precise measurements, increasing the confidence in your assay. Abnormalities, such as bubbles, incorrect volumes, and erroneous concentrations, are easily revealed with the Toximaster® QC8 software. If an out-of-specification problem does arise, the detailed data trends will allow you to easily track it back to its source. Thus, you will be able to identify potential product failures early on.
Excellent data processing and audit trail abilities
Furthermore, the software processes data in a robust manner and calculates mean values and standard deviations. It also has excellent audit trail capabilities, delivering hard copy printouts with all pertinent information for routine audits.
Ideal for the comparative testing and validation of most LAL reagents
The detailed information on the full set of LAL assay data and their statistical evaluation enables an easy comparison and testing of LAL reagents. This renders the Toximaster® QC8 software a valuable tool for the testing and validation of LAL reagents.
The abundance of data and deep insight into data trends that the Toximaster® QC8 software provides have led to its recognition as a valuable addition to bacterial endotoxin testing.
1. Farhana A, Khan YS. Biochemistry, Lipopolysaccharide. [Updated 2021 Apr 29]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2021 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK554414/
2. Novitsky TJ. Biomedical applications of Limulus Amebocyte lysate. J.T. Tanacredi et al. (eds.), Biology and Conservation of Horseshoe Crabs, DOI 10.1007/978-0-387-89959-6_20, Springer Science+Business Media, LLC 2009