Bacterial Endotoxin Testing
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Bacterial endotoxin testing is a crucial step in the development and manufacturing of antibody drugs to ensure their safety and quality. Creative Proteomics specializes in providing comprehensive solutions for the detection of bacterial endotoxins in antibody drugs. With a team of highly skilled professionals and state-of-the-art technology, we offer accurate and reliable testing services to pharmaceutical companies, biotechnology firms, and research institutions worldwide.
Importance of Bacterial Endotoxin Testing
Bacterial endotoxins are potent and harmful substances that can be found in bacterial cell walls. When present in antibody drugs, they pose a significant threat to patient safety and can lead to severe side effects. Detection and quantification of bacterial endotoxins are crucial to ensure the safety and efficacy of antibody drugs before they reach the market.
Our Bacterial Endotoxin Testing Services
Our services include the quantification of bacterial endotoxins present in antibody drugs. We employ validated methodologies and state-of-the-art equipment, such as Limulus Amebocyte Lysate (LAL) assays, to ensure accurate and precise measurements.
Pyrogens, which are fever-inducing substances of microbial origin, can also be present in antibody drugs. We offer pyrogen testing services to determine the presence and level of pyrogens, providing valuable insights into the safety profile of the drugs.
Our experienced scientists can assist in the development and validation of analytical methods for bacterial endotoxin detection. We ensure that the methods used are compliant with regulatory guidelines and industry standards.
Bacterial Endotoxin Testing Methods and Process at Creative Proteomics
Our company follows stringent procedures and utilizes proven methods to perform this testing. Below is a detailed description of our bacterial endotoxin testing methods and procedures:
- Selection of appropriate test method
Depending on the nature of the antibody drug, we choose a suitable bacterial endotoxin testing method. The two commonly used approaches are the Limulus Amoebocyte Lysate (LAL) assay and the recombinant factor C (rFC) assay. Both methods are designed to detect and quantify endotoxins, but they differ in their detection mechanisms.
Before testing, the antibody drug sample is prepared to ensure accurate and representative results. This involves dilution or extraction of the drug from the formulation to create a suitable test solution.
The prepared sample is incubated with the appropriate endotoxin detection reagent, either LAL or rFC. The incubation is performed under controlled conditions to facilitate the reaction between the endotoxins and the detection reagents.
After incubation, the reaction between the sample and the endotoxin detection reagent is examined. This can be done by measuring the change in color or turbidity, which indicates the presence of endotoxins. The detection can be performed using spectrophotometry, specialized assay readers, or visual observation by trained analysts.
Creative Proteomics has extensive project experience in antibody drug characterization, and we have a deep understanding of the time-sensitive nature of antibody drug development. Therefore, we strive to achieve efficient turnaround times for sterile assays without compromising the quality and accuracy of results. For more information or to request our services, please feel free to contact us.
