On February 5 this year, in the Announcement No. 3 of 2021 issued by the National Forestry and Grassland Administration and the Ministry of Agriculture and Rural Affairs, adjustments were made to the "List of National Key Protected Wild Animals", the most noteworthy of which is to upgrade the horseshoe crabs distributed in China to national second-class protected animals.
Bacteria within the pharmaceutical and vaccine industries.
Toxin testing relies on collecting blood from wild horseshoe crabs.
Bacterial endotoxin testing (BET) is an essential safety requirement in the pharmaceutical and biomedical industries. If bacterial endotoxins enter the patient's bloodstream in sufficient concentrations, they can cause harmful symptoms such as fever and septic shock and can be fatal in the most severe cases. Therefore, any drug entering the human body, including parenteral drugs and injectable devices, must be tested for endotoxin in accordance with the requirements of the national pharmacopoeia regulations before being placed on the market.
Horseshoe crab blood is the main raw material of bacterial endotoxin detection reagents**, but it is very difficult to breed horseshoe crabs in captivity, so before horseshoe crabs become national second-class wild protected animals, endotoxin detection reagents mainly rely on collecting the blood of wild horseshoe crabs.
The importance of LAL protection for endotoxin testing.
In the United States, bacterial endotoxin testing relies on a reagent called the LAL reagent extracted from the blood of wild Atlantic horseshoe crab (Limulus polyphemus) that inhabits the eastern coastal areas of the United States. In Southeast and East Asia, another three species of horseshoe crab (Tachypleus spp.) are collected) to produce another bacterial endotoxin detection reagent, called a TAL reagent. TAL is mainly used in the Asian range, while LAL is used globally.
Because LAL reagents rely on collecting the blood of wild horseshoe crabs, it is important to protect the global horseshoe crab population. In the United States, various conservation measures have been widely successful in ensuring sustainable harvesting practices. However, the situation is more severe in Asia, where unsustainable blood collection methods for TAL production and over-harvesting have led to a severe decline in horseshoe crab populations. This poses a serious challenge to the conservation of horseshoe crabs.
Lonza's commitment to sustainability.
At Lonza we are aware of the importance of LAL to improve the safety of pharmaceuticals and medical devices and their ecological role. We actively support the conservation of horseshoe crabs and are committed to the stability and sustainability of the ** chain.
Lonza used Lonza's approved best practices to handle the horseshoe crabs in the manufacture of LAL reagents, and they returned to their original waters alive.
Lonza employees are releasing horseshoe crabs.
With these factors in mind, Lonza has also developed a new solution, an alternative BET method that does not rely on the collection of horseshoe crab blood: Pyrogene RFC Recombinant Factor C Assay. The use of recombinant C-factor alternatives can reduce the need for horseshoe crabs and help meet the sustainability of the ** chain.
Eli Lilly's monoclonal antibody Emgality (galcanezumab) was approved by the US FDA in 2018.
Lonza has developed.
Four main types of bacterial endotoxin test methods.
Qualitative Method: Answer Yes or No.
Gel-based LAL analysis: Simple LAL analysis to visually check the formation of gels.
Quantitative method: The specific content was calculated according to the standard curve.
Chromogenic LAL Analysis: Dynamic or end-point chromogenic measurement that quantifies the endotoxin concentration in the measured sample.
Turbidimetric LAL analysis: dynamic detection of turbidity formation is a cost-effective method for endotoxin detection in water samples or high-dose parenteral drugs.
Recombinant factor C analysis: a non-animal substitute for LAL, based on the recombinant expression of the production of factor C, which is the first component in the coagulation cascade of horseshoe crab and does not rely on horseshoe crab blood as a reagent raw material.
Any of Lonza's quantitative testing products can be automated to meet higher throughput testing needs.
Pyrotec Pro platform: Automated solution for endotoxin testing with WinkQCL software.