Protecting Health

Bacterial Endotoxin Test Manufacturers & 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. However, unlike in the United States where the harvest of horseshoe crabs are strictly regulated, most of the animals used in the production of TAL come from areas in Southeast Asia where harvesting regulations have not been established or enforced. Alternative endotoxin tests such as recombinant Factor C (rFC) do not require the blood of a horseshoe crab species, therefore are not geographically dependent. The following lists the manufacturers who produce LAL, TAL and the alternative endotoxin test rFC. This information was provided by each company.

Associates of Cape Cod (LAL)
(A wholly owned subsidiary of Seikagaku Corporation, Japan)
East Falmouth, Massachusetts, USA
www.acciusa.com

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Associates of Cape Cod Inc. (ACC) has always, and will always deeply care for the resource on which we depend on for the manufacture our products. ACC routinely participates in meetings of a local Horseshoe Crab Conservation Committee and has been instrumental in influencing state regulation to increase protection of horseshoe crabs. ACC participates in, and supports science based conservation efforts that include working with state and federal regulators, fisherman, dealers and the community.

  • Associates of Cape Cod financially supports ERDG’s efforts to build community awareness for the world’s four horseshoe crab species.
  • ACC is required to collect data on the sex and condition of every crab that enters our facility. This data is reported to the fishery managers of both MA and RI who in turn report this data to the Atlantic States Marine Fisheries Commission (ASMFC).
  • ACC has used a minimum size requirement for crabs for over 40 years. As a result both RI and MA have adopted a similar size requirement in their respective regulations.
  • At ACC all crabs that will be returned to the sea are marked with non-toxic paint to prevent recapture during the same year. This ensures crabs are bled only once per season. These crabs are returned to the water from which they came within 26 hours of being delivered to the facility.
  • Since the year 2000 ACC has also worked with the State fisheries managers, fisherman and dealers to best utilize the resource that is caught for and by the bait market. The aptly named” rent a crab” program helps to reduce the overall impact of mankind by allowing crabs caught under a bait permit to first be used in the process of manufacturing LAL, before being returned to the bait vendor. This duel use of the bait crabs benefits the fishing community, the biomedical community and the horseshoe crab population. By utilizing many crabs that are entering the bait market anyway, there is a reduced impact on crab populations overall.
  • As part of the Massachusetts regulations, biomedical vendors are required to abide by relevant best management practices such as refrigerated transport, marking of the crabs and return to sea as part of the permitting process. ACC works only with vendors who are capable of and abide by the best management practices relevant to their operation.
  • ACC cooperates with the State Division of marine Fisheries in their work to regulate the horseshoe crab fishery and has a representative seated on the Advisory panel to the Horseshoe Crab management Board of the Atlantic States Marine Fisheries Commission (ASMFC).
  • In 2018 ACC introduced their Horseshoe Crab Sustainability Project to help ensure a stable supply of horseshoe crabs.

Charles River (LAL, TAL)
(Formally Endosafe®)
Charleston, South Carolina, USA

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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.

FUJIFILM Wako Chemicals U.S.A. Corporation (LAL)
(division of FUJIFILM Wako Pure Chemicals Corporation, Japan)
Richmond, Virginia, USA
www.wakopyrostar.com

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“FUJIFILM Wako Chemicals U.S.A. Corporation 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.”

FUJIFILM Wako Chemicals U.S.A. Corporation financially supports ERDG’s efforts to build community awareness for the world’s four horseshoe crab species.

FUJIFILM Wako Pure Chemicals Corporation (LAL)
(Parent company of FUJIFILM Wako Chemicals U.S.A. Corporation)
Chuo-ku, Osaka 540-8605, Japan

Fuzhou Xinbei Biochemical Industrial Co., Ltd (TAL)
Fuzhou 35010, China

Hyglos GmbH – a bioMérieux company (rFC)
(division of bioMérieuxSA, France)
Munich South Bernried, Bavaria, Germany
www.biomerieux-industry.com/Endotoxin

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“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®, ENDOZYME® II and ENDOZYME® II GO bring important advantages such as specificity, robustness, speed and ease-of-use to biopharmaceutical research and industry, overcoming limitations of the LAL test which still relies on lysate from the blood of the horseshoe crabs. Our company philosophy is based on a sustainable approach, learning from nature, instead of exploiting her, in order to create advanced bioanalytical solutions.”

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

Lonza Walkersville, Inc. (LAL, TAL, rFC)
(division of Lonza Group, Switzerland)
Walkersville, Maryland, USA
www.lonza.com

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“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 sits 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.

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

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

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

Zhanjiang Bokang Marine Biological Co. Ltd. (TAL)

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