Bacterial Endotoxin (LAL) Test for Live Biotherapeutic Products

Reliable and efficient testing for the presence of bacterial endotoxins is essential in the pharmaceutical and biomedical industries for live biotherapeutic products. Creative Biolabs is an industry leader in biological safety tests for live biotherapeutic products. We could offer the LAL assay, which is known to be a powerful endotoxin test with high reliability, sensitivity, and specificity for high throughput testing needs.

Bacterial Endotoxins Test (BET)

Endotoxins, a type of pyrogen, are chemical compounds from the external cell membrane of gram-negative bacteria. These components are the most common cause of toxic reactions causing a pyrogenic response. Endotoxins may decrease the effectiveness of a therapeutic product and cause adverse reactions and numerous other severe biological effects, including aseptic shock and potentially death. For these reasons, live biotherapeutic products require bacterial endotoxin testing (BET) to detect and quantify the presence of endotoxins. There are several methods available for conducting the BET; among them, the most common approach to endotoxin testing is the Limulus amoebocyte lysate (LAL) test. LAL test identifies pyrogenic responses to determine the presence of bacterial endotoxins, and this LAL test is a standard test for endotoxins and is widely used for the detection and quantification of bacterial endotoxins.

LAL Test at Creative Biolabs

Endotoxin testing of biologicals manufactured in bacteria is a necessity to ensure that the live biotherapeutic products are endotoxin-free. Creative Biolabs is at the forefront in the evolution of endotoxin testing and the development of live biotherapeutic products. Therefore, we now offer the LAL test, which is a highly reliable, sensitive, and specific method available to detect the presence and quantification of bacterial endotoxins.

At Creative Biolabs, we can accomplish endotoxin test by various options, including but not limited to:

• Gel-Clot Method - Qualitative or semi-quantitative
• Kinetic Chromogenic Method - Quantitative with low limits of detection: based on the producing color after cleavage of a synthetic peptide-chromogen complex
• Kinetic Turbidimetric Method - Quantitative with the lowest limits of detection: based on forming turbidity after cleavage of an endogenous substrate
• Recombinant Factor C assay - Animal-free
• Custom Method Development and Validation

Creative Biolabs will help you choose the most suitable type of LAL testing method to meet the needs of your application. These tests can be carried out relatively quickly, and results can be available within several days of sample receipt.

Advantages of Our LAL Test Service

• Select the most appropriate method for your specific products
• Flexible methods and platforms meet the specific needs
• Good linearity and good reproducibility
• High sensitivity and broad application range
• Fast turnaround time and competitive price

Creative Biolabs is a leading service provider with many years of experience in the testing of live biotherapeutic products. Our skilled technical team backs every LAL test system for bacterial endotoxin. To learn more about our endotoxin testing services, please contact us .

For Research Use Only. Not intended for use in food manufacturing or medical procedures (diagnostics or therapeutics). Do Not Use in Humans.