Bacterial Endotoxin Test
Overview Services Applications Advantages FAQs
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.
Overview of Bacterial Endotoxins Test
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, this LAL test is a standard test for endotoxins and is widely used for the detection and quantification of bacterial endotoxins.
Bacterial Endotoxins Test Service
Endotoxin testing of biologicals manufactured in bacteria is a necessity to ensure that the live biotherapeutic products are endotoxin-free.
Testing Methods
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Gel-Clot Method - Qualitative or semi-quantitative.
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Kinetic Chromogenic Method - Quantitative with low limits of detection: based on the producing color after cleavage of a synthetic peptide-chromogen complex.
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Kinetic Turbidimetric Method - Quantitative with the lowest limits of detection: based on forming turbidity after cleavage of an endogenous substrate.
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Recombinant Factor C assay - Animal-free.
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Custom Method Development and Validation.
Testing Standards
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ANSI/AAMI ST72
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USP <161> and <85>
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EP 2.6.14
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Other similar standards.
Samples Types
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Drug formulations
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Raw materials
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Excipients
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Water for injection
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APIs
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Powder
Turnaround Time
From 4-6 weeks.
Deliverables
Upon completion of the testing services, a final report will be issued.
Applications
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Reduce R&D costs.
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Improve product quality.
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Import and export of products.
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Product quality control.
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Publish scientific research.
Advantages
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Select the most appropriate method for your specific products.
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Flexible methods and platforms meet the specific needs.
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Good linearity and good reproducibility.
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High sensitivity and broad application range.
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Fast turnaround time and competitive price.
Frequently Asked Questions
Why is the bacterial endotoxin test necessary?
The bacterial endotoxin test (also known as the Limulus Amebocyte Lysate or LAL test) is crucial for several reasons:
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Safety Assessment: It quantifies endotoxins present on the cell walls of gram-negative bacteria.
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Pyrogenic Nature: Endotoxins are pyrogenic, meaning they can induce fever and other inflammatory responses in humans.
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Quality Control: The LAL test is essential for in-process and final product release testing of sterile pharmaceuticals and medical devices.
Which types of products should be tested for bacterial endotoxin?
Here are the key types of products that should undergo BET:
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Injectable Drugs: All parenteral drugs, such as vaccines, antibiotics, and biologics, require BET.
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Implantable Medical Devices.
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Raw Materials: Raw materials used in drug formulation, including water, excipients, and active pharmaceutical ingredients (APIs), should be tested for endotoxins.
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In-Process Samples: During manufacturing, in-process samples are tested to monitor endotoxin levels and ensure product quality.
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.
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