USP Approvement of Non-Animal Reagents for Endotoxin Testing

Future Drug Testing

Limulus Amebocyte Lysate (LAL) reagent is a reagent derived from the blood cells of horseshoe crabs, relying on natural resources. In March 2019, the International Union for Conservation of Nature (IUCN) classified the Chinese horseshoe crab as endangered.

With the increasing variety of bacterial endotoxin tests year by year, the demand for LAL reagents in various countries has also been increasing. The conflict between the demand for LAL reagents and the conservation of horseshoe crab resources has promoted the development of supplementary alternative methods for endotoxin testing. Endotoxin content must be tested in biologics, injectable drugs, chemical drugs, radiopharmaceuticals, antibiotics, vaccines, mRNA and plasmid drugs, cell therapy and gene therapy, and medical devices (such as disposable syringes and implantable biomaterials) and is used as a quality standard for final product release.

Endotoxin Detection Methods

There are four main methods for detecting endotoxins: Rabbit Pyrogen Test (RPT), Monocyte Activation Test (MAT), Limulus Amebocyte Lysate (LAL) test, and Recombinant Factor C (rFC) test.

1. Rabbit Pyrogen Test (RPT)
2. Monocyte Activation Test (MAT)
3. Limulus Amebocyte Lysate (LAL) test
4. Recombinant Factor C (rFC) test
5. 
   

With the formal inclusion of recombinant cascade reagent (rCR) and recombinant factor C reagent (rFC) in Chapter <86> of the United States Pharmacopeia-National Formulary (USP-NF), pharmaceutical manufacturers will be able to adopt more advanced and sustainable testing methods. This will improve the quality and safety of drugs while reducing reliance on animal-derived reagents. This change not only responds to global concerns about animal welfare but also reflects advancements in biopharmaceutical testing technology. This move will have a profound impact on global drug safety standards and lay a solid foundation for the future development of drug testing technologies.

New Product Release

Protect Endangered Animals, Reject "Horseshoe" Blood!

Accurate Endotoxin Measurement, We Have New Methods

Hzymes Biotech's Recombinant C Factor Endotoxin Detection Kit expresses C factor recombinant protein through gene recombination. The recombinant C factor is activated by binding to endotoxins, which then cleaves a fluorescent substrate to release free fluorescent groups. The release of fluorescent groups is proportional to the concentration of endotoxins, allowing quantitative detection of endotoxin content. Compared with LAL reagents, the Recombinant C Factor Endotoxin Detection Kit has better specificity, precision, accuracy, linear range, and quantitative limits, making it the future mainstream method for endotoxin detection.

Product Performance

• Easy Operation: One-step detection, endpoint fluorescence determination, detection time only 90 minutes.
• Excellent Performance: High sensitivity (0.005EU/mL~5EU/mL), good batch-to-batch and intra-batch consistency, and sample recovery rate meets standards.
• Exclusive Specificity: No G factor bypass interference, suitable for endotoxin detection in samples with β-glucan interference, avoiding false positives.
• Long Stability: The lyophilized standard can be stored at 4°C for up to 60 days after reconstitution, and the kit can be stably stored for 1 year.
• Wide Applicability: Suitable for different types of sample detection, sample measurements can correspond to LAL reagents, and applicable to multiple microplate readers.

Product Ordering

1. HBP008001-1 48T
2. HBP008001-2 96T