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.”
Nephron employees achieve Lean Six Sigma green belt certification see more
If there were ever a time for improved efficiency to help a fast-moving company, it would be now for Nephron Pharmaceuticals Corp.
With the West Columbia-based manufacturer of sterile respiratory medication churning out product at a record pace during the COVID-19 health crisis, owner and CEO Lou Kennedy is in search of every competitive advantage available.
“In spite of my Southern accent, I do move like a New Yorker, and this company goes at that pace,” she said. “It’s a testament to the team here that everybody’s running on high-test, premium unleaded, and keeping up.”
The most recent example came when nine Nephron employees achieved Lean Six Sigma green belt certification after completing courses at the University of South Carolina’s Darla Moore School of Business. Six Sigma or lean manufacturing, pioneered by the likes of Henry Ford and famously implemented by Toyota in the years following World War II, is a systematic method aimed at reducing waste and variation to improve production quality and efficiency.
Nephron Pharmaceuticals Corporation expanding operations again, adding 380 jobs, $215.8 million investment$215.8 million investment will create 380 new jobs in Lexington County, SC see more
Nephron Pharmaceuticals Corporation (Nephron), a global leader in the production of generic respiratory medications and blow-fill-seal contract manufacturing, today announced plans to expand operations in Lexington County. The company's $215.8 million investment will create 380 new jobs.
A West Columbia, S.C.-based company, Nephron develops and produces safe, affordable generic inhalation solutions and suspension products, including those used to treat severe respiratory distress symptoms associated with COVID-19.
The company also operates an industry-leading 503B Outsourcing Facility division which produces pre-filled sterile syringes and IV bags for hospitals across America, in an effort to alleviate drug shortage needs. Nephron fills the needs of patients and health care professionals as they arise nationwide, and recently opened a CLIA-certified diagnostics lab.
Headquartered at 4500 12th Street in West Columbia, Nephron’s expansion will add new offices, a new warehouse and production space at its campus in Saxe-Gotha Industrial Park.
The expansion is expected to be completed by Q1 of 2021. Individuals interested in joining the Nephron team should visit https://www.nephronpharm.com/careers.
The Coordinating Council for Economic Development has approved job development credits related to this project.
“The Nephron family is extraordinarily grateful for the opportunity to grow in South Carolina. Thanks to our partnerships with state and local officials, and the trust they have placed in us, we have been able to provide life-saving medications to patients around the world and establish ourselves as the global leader in what we do. We are proud of these achievements and more, and we know our best days are ahead of us. That is what makes this latest announcement so special.” -Nephron Owner & CEO Lou Kennedy
“We are proud to have Nephron Pharmaceuticals in South Carolina. Since coming here they have become an integral part of the community, and recently have been vital in the fight against COVID-19. This new investment of more than $215 million creating 380 new jobs in Lexington County is a great win for Team South Carolina.” -Gov. Henry McMaster
“Nephron is a longtime steward of South Carolina’s business community, and we congratulate them on their continued growth within our state. Today’s announcement is yet another big win for South Carolina, our people and our burgeoning life sciences sector.” -Secretary of Commerce Bobby Hitt
“We are excited to continue to partner with such an innovative and forward-thinking company like Nephron Pharmaceuticals. We know that Lexington County is a great place to establish and grow a business, and Nephron’s continued success is a testament to good government-business relations.” -Lexington County Council Chairman Scott Whetstone
FIVE FAST FACTS
• Nephron Pharmaceuticals Corporation (Nephron) is expanding operations in Lexington County.
• The $215.8 million investment is projected to create 380 new jobs.
• Nephron is a global leader in the production of generic respiratory medications and blow-fill-seal contract manufacturing.
• Headquartered at 4500 12th Street in West Columbia, S.C.
• Individuals interested in joining the Nephron team should visit https://www.nephronpharm.com/careers.
Nephron seeks to stem coronavirus concerns with expanded offerings see more
In response to the novel coronavirus pandemic, West Columbia-based Nephron Pharmaceuticals Corp. has asked the Food and Drug Administration for permission to add up to six filling lines to ramp up its production of sterile respiratory medication.
Nephron CEO Lou Kennedy said she spoke with the FDA on Tuesday morning and is “waiting to hear back.” Kennedy also said Nephron will begin making its own hand sanitizer as early as this week.
Nephron, which CEO Lou Kennedy said is one of two companies in the U.S. that produce 98% of the nebulizer solutions used in hospitals or sold in retail outlets, relocated to South Carolina from Florida in 2014.
“We didn’t move all the equipment right away,” moving an additional six filling lines to South Carolina in 2019, Kennedy said. She said she had been in discussion with the FDA for permission to bring those machines online. A meeting had been scheduled for March 22 before she made another request Tuesday.
West Columbia-based Nephron has asked for FDA approval to add up to six filling lines for its respiratory medication manufacturing. CEO Lou Kennedy also announced the company will begin making hand sanitizer this week. (Photo/File)
The eight filling lines currently being used in production of the inhalation solutions Nephron makes typically produce 80 to 85 million doses a month “on a regular basis” and are capable of making up to 110 million monthly doses, Kennedy said.
“As of yesterday, we had orders on the books for 87 million, so already a month’s worth,” Kennedy said. “For the last two weeks, those orders have been running about 48% higher than we would normally see. … We do have backstock that we’ve built up in inventory, (but) that won’t last forever.”
To maximize Nephron’s 24-hour, seven-day-a-week production schedule, Kennedy said the company has begun providing in-house child care. Children are provided food, and already stringent cleaning efforts have been “tripled,” Kennedy said. She said the same methods used to maintain sterile facility conditions, including the use of a fogging machine and wiping down surfaces with isopropyl alcohol and hydrogen peroxide, are being deployed in the day care.
“We’re really good at cleaning here, because we only make sterile drugs,” Kennedy said. “I’m very confident about making a clean environment for these children.”
During a conference call Tuesday, Kennedy also said Nephron has received FDA approval to begin making its own hand sanitizer and ordered supplies to do so on Monday.
“We will take care of the Nephron family first, and after we do that, we will look at should we go through churches, the Salvation Army, how can we help the community, and/or commercial production,” she said. “I’ve had at least six requests from various sales reps across the country. Hospitals are asking can we make that hand sanitizer for them.”
The plan is to produce 50-liter batches of a strong, FDA recipe without fragrances or other diluting agents, Kennedy said. She said she will gift what is left over from the first batch, after Nephron employees and their families have been served, to local charities.
Kennedy said as early as December, Nephron began taking stock of things such as the resin used to make vials of its liquid medication as well as its supply of active pharmaceutical ingredients. “We are fortunate that we have more than a year’s supply of that (API) on hand,” she said.
Nephron makes bronchodilators including albuterol used to treat respiratory illnesses such as bronchial asthma, pneumonia, emphysema and croup. It also manufactures Pocket Nebs, which are portable, battery-charged nebulizers.
Novel coronavirus can cause cough, shortness of breath and breathing difficulties. Severe infections can lead to complications including pneumonia, according to the World Health Organization.
Increased product demand during cold, cough and allergy season, as well as past experience with respiratory illnesses including SARS and H1N1, have made the company ever-vigilant, Kennedy said.
“We make sure to be very rock-solid in our preparation to accommodate the needs of America,” she said.
Kennedy said hiring and training has already begun in anticipation of FDA approval of the additional filling lines.
“We have the people to be able to ramp that up right now,” she said. “ … If we don’t get our hands wrapped around this quickly, meaning we squelch the spread, get control of the spread, it’s going to be a long, hard road. But it’s easily solved if the FDA allows me to ramp up the five or six other lines that I brought here from Florida.”