Endotoxin Testing Manufacturers and Conservation

As the Limulus polyphemus species is only found in the United States, LAL is manufactured in the United States.  It is, however, sold globally.  Tachypleus tridentatus is a species located in Asia.  TAL is therefore manufactured in Asia and is typically only sold in Asia.

United States Manufacturers (LAL)

Horseshoe crabs are found on the east coast of the United States, so the country's LAL manufacturers are located there as well.  At right is basic contact information on each LAL manufacturer and their conservation efforts.  The conservation information was provided by each company and published in October 2008 in the LAL Users’ Group Newsletter (published by the LAL Users’ Group and the Pharmaceutical Microbiology Forum). 

Additional information on each company and their horseshoe crab conservation or sustainability efforts may be found on each company’s website.

Associates of Cape Cod
(division of Seikagaku Corporation, Japan)
East Falmouth, Massachusetts, USA
www.acciusa.com 
"Associates of Cape Cod, Inc. (ACC) serves on the local Horseshoe Crab Conservation Committee and has been instrumental in influencing State regulation to increase protection of horseshoe crabs. ACC cooperates with the State Division of Marine Fisheries in their work to regulate the horseshoe crab fishery and is represented on the Advisory Panel to the Horseshoe Crab Management Board of the Atlantic States Marine Fisheries Commission. ACC is regularly involved in education programs, both independently and with other organizations, including the Massachusetts Audubon Society and the Green Eggs and Sand Program run by the Maryland Department of Natural Resources."

Charles River
(Formally Endosafe®)
Charleston, South Carolina, USA
www.criver.com 
Charles River is in a unique position regarding the horseshoe crab population in South Carolina (the location of Charles River’s crab bleeding facility). Prior to 1991, there were no laws or regulations in South Carolina dealing with horseshoe crabs. Increased fishing industry demands for Limulus polyphemus made it necessary to develop a state-wide management plan to conserve this resource. In 1992, Dr. James Cooper (a pioneer in the research and development of the LAL assay and Endosafe® company founder) and his wife Francis initiated a dialogue with the Atlantic States Marine Fishery Commission (ASMFC) and the South Carolina Department of Natural Resources and wrote draft legislation that called for the management and regulation of horseshoe crab fisheries. As a result, the South Carolina state legislature enacted laws to protect the indigenous horseshoe crab population. In South Carolina, horseshoe crabs must be harvested by hand, and can only be used for biomedical applications (LAL production) and marine biological research, and not as bait for the eel and whelk industries. The addition of six island sanctuaries makes the horseshoe crabs in South Carolina one of the most protected species in South Carolina.  This proactive legislation and the controlled (and monitored) bleeding and horseshoe crab handling procedures have created a significantly increasing population of horseshoe crab in South Carolina.

Charles River is committed to employing only fishermen licensed by the Department of Natural Resources to hand-harvest horseshoe crabs from the coastal waters of South Carolina. Once the crabs are brought into the lab, they are carefully inspected by trained employees who determine the animal’s health and maturity. After careful collection of a measured amount of blood, the crabs are returned unharmed to their natural habitat within the same day.

Charles River financially supports ERDG’s efforts to build community awareness for the conservation of the world’s four horseshoe crab species.

Lonza Walkersville, Inc.
(division of Lonza Group, Switzerland)
Walkersville, Maryland, USA
www.lonza.com
At Lonza, we are aware of the importance of the horseshoe crab for its contribution to the safety of drugs and medical devices but also its role in the circle of life. Lonza does not sell the horseshoe crabs that we use for biomedical purposes after bleeding, they are returned alive to the same waters from which they were taken. We have a representative who sist on the Atlantic States Marine Fisheries Commission (ASMFC) Advisory Panel for the horseshoe crab. Annually we donate funds to support educational programs and help coastal communities save the horseshoe crab breeding grounds. In addition, we have developed an alternative endotoxin detection assay that does not rely upon horseshoe crab blood. The PyroGene™ assay uses a recombinant form of the horseshoe crab Factor C to detect endotoxin. With the PyroGene™ assay, there is less dependence on the animal and less animal utilization. At Lonza, we strive to help protect the future generations of the horseshoe crab.” 

Lonza financially supports ERDG’s efforts to build community awareness for the conservation of the world’s four horseshoe crab species. For more information on sustainability efforts visit, www.lonza.com/hsc.

Wako Chemicals, USA
(division of Wako Pure Chemicals, Japan)
Richmond, Virginia, USA
http://www.wakopyrostar.com/
"Wako Chemicals USA, Inc. is very much concerned with maintaining the viability of the horseshoe crab population. We are dedicated to following practices that ensure the careful handling and good quality of crabs used for LAL manufacture that both minimize injury and protect this invaluable species. After bleeding, the crabs are returned the next day by our fisherman to the same waters where they were collected. To assist in the collection of data for crab conservation studies, Wako USA participates in a horseshoe crab tagging and monitoring program coordinated by the U.S. Fish and Wildlife Service.”

Wako financially supports ERDG’s efforts to build community awareness for the world’s four horseshoe crab species.

Hyglos GmbH – a bioMérieux company
(division of bioMérieuxSA, France)
Munich South Bernried, Bavaria, Germany
www.hyglos.com
"Hyglos GmbH, founded in 2009, is a biotech company with a scientific team dedicated to the development of innovative methods in the field of endotoxin detection. The Hyglos methods do not rely on Horseshoe crab-derived reagents. The recombinant factor C reagent is produced using the cloned gene from horseshoe crabs and is produced in cell culture. The EndoLISA phage proteins are similarly produced. Both the Phage Recombinant Proteins and Recombinant Horseshoe Crab Factor C (rFC) are completely free from animal-derived components. Our endotoxin tests EndoLISA® and EndoZyme® bring important advantages to users in biopharmaceutical research and industry, overcoming limitations of the LAL test (Limulus amebocyte lysate) which still relies on lysate from the blood of the horseshoe (Limulus) crab. Our company philosophy is based on a sustainable approach, learning from nature, instead of exploiting her, in order to create modern analytical solutions."

Hyglos GmbH - a BioMérieux company financially supports ERDG’s efforts to build community awareness for the world’s four horseshoe crab species.

Asia Manufacturers (TAL)

In Asia, TAL is manufactured in China and Japan.  However, most of the animals used come from areas in Southeast Asia where harvesting regulations have not been established or enforced. The following lists the manufacturers located in Asia.  Some are affiliated with US manufacturers and therefore may also sell LAL in Asia.  Less is known regarding their horseshoe crab collection and handling practices, although US-based LAL vendors have shared their best practices with them.

Fuzhou Xinbei Biochemical Industrial Co., Ltd
Fuzhou 35010, China

Seikagaku Corporation (Parent company of Associates of Cape Cod, USA)
Chiyoda-ku, Tokyo 100-0005, Japan
www.seikagaku.co.jp

Wako Pure Chemical Industries, Ltd. (Parent company of Wako Chemical, USA)
Chuo-ku, Osaka 540-8605, Japan
www.wako-chem.co.jp

Xiamen Chinese Horseshoe Crab Reagent Manufactory Co., Ltd.
Haicang, Xiamen, Fujian, 361022 China
www.houshiji.com

Zhanjiang A&C Biological Ltd.
Division of Charles River Laboratories, USA
Zhanjiang, Guangdong 524022, China
www.zacb.com

Zhanjiang Bokang Marine Biological Co. Ltd.

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