Charles River offers rebuttal to earlier article see more
As a native South Carolinian and senior corporate vice president of Charles River Laboratories in Charleston, I was appalled by the inaccurate accusations from Defenders of Wildlife in an Oct. 10 op-ed, “Cape Romain is protected, but work remains to safeguard SC’s horseshoe crab.” Out-of-state environmentalists are irresponsibly using misinformation that could put your health at risk, and that is dangerous.
The facts and the science are clear: The Limulus amebocyte lysate (LAL) obtained from the Atlantic horseshoe crab is critical to the safety of patients around the globe. This unique, natural substance is used to test every injectable pharmaceutical and implantable medical device, including every approved COVID-19 vaccine, for contamination. Without these tests, endotoxins could enter your body and produce sepsis, which can be life-threatening.
Charles River has been manufacturing these tests in Charleston County for more than 34 years. We have invested more than $70 million in our operation over the past 25 years and employ more than 300 people. We take pride in our work in developing quality control microbial testing solutions globally and servicing more than 6,000 customers in 101 countries.
Recently, we have been responding to a variety of concerned special-interest groups over the use of horseshoe crab blood within the biopharmaceutical industry. We welcome questions and conversations on this topic. These are the facts: We partner with licensed local fishermen to hand-collect horseshoe crabs. They are transported to our facility in Charleston County, where they are cleaned, and we extract a portion of their blood. They are then returned to the water, unharmed. All of this we strive to complete within 24 hours.
Last week, Christian Hunt of Defenders of Wildlife wrote that a synthetic alternative to FDA-approved LAL tests is “readily” available. This is incorrect. Synthetic LAL is not readily available, and more importantly, it is not licensed by the FDA. While offered for a very narrow sampling of pharmaceuticals, no industry leader has moved 100% to synthetic LAL. Why? If we stop using horseshoe crab-derived LAL, we cannot guarantee the safety of IVs, syringes and vaccines, among many other medical products. This is an unacceptable risk to patient safety.
This does not mean alternatives may not be viable one day. Charles River is researching, and will continue to study, alternative ways to do what we do best: keep patients safe from bacteria and infection when they are in their most vulnerable medical state. We are investing in the research and development of our own synthetic alternatives. While we work to prove these alternatives are safe and effective, we are also reducing how much horseshoe crab-derived LAL is required for each test. Our FDA-licensed LAL cartridge technology reduces the amount of raw LAL needed by 95%.
Charles River is committed to doing what’s right, which is why we supported legislation to ban the use of horseshoe crabs as bait for eel and welk in the Southeast. South Carolina is the only state with this protection.
The Oct. 10 op-ed claimed that “DNR noted as early as 2012 that ‘worrisome’ decline in crab sampling were correlated with increases in harvesting,” but that information is based on a nearly decade-old report. A more current report, released in 2019 by the Atlantic States Marine Fisheries Commission, stated that horseshoe crab populations are strong along South Carolina’s coast.
South Carolina is in a unique and critical position of leadership in the global biopharmaceutical supply chain. Over the past few months, our company has been meeting with S.C. environmental groups and local leaders to have honest conversations. We live here, and we care about wildlife and the environment. We want to work with all reasonable parties to maintain the critical balance between protecting the environment and ensuring that our global public health system is safe and effective.
Visit hsc.criver.com/south-carolina.html for more facts and information.
Charles River Labs quietly continues its critical work to save lives see more
CHARLESTON, S.C. (AP) — It’s one of the stranger, lesser-known aspects of U.S. health care — the striking, milky-blue blood of horseshoe crabs is a critical component of tests to ensure injectable medications such as coronavirus vaccines aren’t contaminated.
To obtain it, harvesters bring many thousands of the creatures to laboratories to be bled each year, and then return them to the sea — a practice that has drawn criticism from conservationists because some don’t survive the process.
The blood, which is blue due to its copper content, is coveted for proteins used to create the LAL test, a process used to screen medical products for bacteria. Synthetic alternatives aren’t widely accepted by the health care industry and haven’t been approved federally, leaving the crabs as the only domestic source of this key ingredient.
Many of these crabs are harvested along the coast of South Carolina, where Gov. Henry McMaster promoted the niche industry as key to the development of a domestic medical supply chain, while also noting that environmental concerns should be explored.
“We don’t want to have to depend on foreign countries for a lot of reasons, including national security, so it’s good to see this company thriving in the United States,” McMaster told The Associated Press. He spoke this month during a visit to Charles River Laboratories at its Charleston facilities, to which AP was granted rare access. “We want to do everything we can to onshore all of these critical operations.”
Horseshoe crabs — aquatic arthropods shaped like helmets with long tails — are more akin to scorpions than crabs, and older than dinosaurs. They’ve been scurrying along the brackish floors of coastal waters for hundreds of millions of years. Their eggs are considered a primary fat source for more than a dozen species of migratory shore birds, according to South Carolina’s Department of Natural Resources.
Their value to avoiding infection emerged after scientists researching their immune response injected bacteria into horseshoe crabs in the 1950s. They ultimately developed the LAL test, and the technique has been used since the 1970s to keep medical materials and supplies free of bacteria.
Their biomedical use has been on the rise, with 464,482 crabs brought to biomedical facilities in 2018, according to the Atlantic States Marine Fisheries Commission.
In South Carolina, that’s done only by Charles River, a Massachusetts-based company that tests 55% of the world’s injectables and medical devices — like IV bags, dialysis solutions and even surgical cleaning wipes, according to company officials.
“We are almost the last line of defense before these drugs leave the manufacturing area and make it to a patient,” senior vice president Foster Jordan told McMaster. “If it touches your blood, it’s been tested by LAL. And, more than likely, it’s been tested by us.”
Charles River employs local fishermen to harvest the crabs by hand, a process governed by wildlife officials that can only happen during a small annual window, when the creatures come ashore to spawn.
Contractors bring them to the company’s bleeding facilities, then return them to the waters from which they came. During a year, Jordan said his harvesters can bring in 100,000 to 150,000 horseshoe crabs, and still can’t satisfy the growing demand.
“We need more, though,” Jordan told McMaster, adding that his company is working with the state to open up more harvesting areas. “The population’s steady. ... We need access to more beaches, to get more crabs.”
The practice is not without its critics, some of whom have argued that bleeding the crabs and hauling them back and forth is harmful. According to the National Oceanic and Atmospheric Administration, 10% to 15% of harvested crabs die during the process.
The International Union for Conservation of Nature listed the species overall as “vulnerable,” noting decreasing numbers as of a 2016 assessment. The Atlantic States Marine Fisheries Commission listed 2019 stock as “good” in the Southeast, but “poor” in areas around New York.
Conservationists sued last year, accusing the U.S. Fish and Wildlife Service of shirking its duty to protect areas including South Carolina’s Cape Romain National Wildlife Refuge by allowing horseshoe crab harvesting. They argued that taking out the crabs affects other species in the protected area. A federal judge temporarily halted the harvest, but was reversed following Charles River’s appeal.
The environmental groups asked to withdraw their complaint this month after federal officials imposed a permitting process for any commercial activity in the refuge, including horseshoe harvesting, beginning Aug. 15. Even if such permits are denied, Jordan told McMaster that only 20% of its harvest came from the refuge, with most coming from further down the South Carolina coast.
There is a synthetic alternative to the horseshoe crab blood, but it hasn’t been widely accepted in the U.S., and meanwhile, Charles River’s international competitors are making synthetics and also pressing for U.S. Food and Drug Administration approval, which Jordan said could hamper domestic efforts like his own.
“My mission is to make sure that any competitor that comes into the United States, from China or any of these other producers, has to go through the same regulatory process that we had to go through, to make sure that it’s safe,” Jordan said. “If all these synthetics start coming in from other countries, we’re going to lose the protection that we’ve had for all these years, and the safety, and the control of the drug supply.”
“We want to have as much stuff made here as we can,” McMaster said in response.
As for the environmental concerns, the governor said maintaining a healthy balance between scientific demands and the state’s ecosystems, which bolster a significant portion of South Carolina’s tourism economy, is paramount.
“It’s like a house of cards. You pull out one part, and the rest of it will fall,” McMaster said. “So I think we have to be very careful, and be sure that any company, any business, any activity, whether it’s commercial or otherwise, meets whatever requirements are there to protect the species — birds, horseshoe crabs, any sort of life.”
South Carolina's life sciences industry is booming. Read on for details... see more
From pharmaceuticals and medical devices to research and laboratory testing, the state's life sciences field is booming. The Charleston and Lowcountry region is home to many established companies and start-ups making a mark on the biomedical and health industries. Read on for the full story from Charleston Business Magazine's 2018 State of the Lowcountry Report.