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Charles River Labs

  • sam patrick posted an article
    Rebuttal to a factually inaccurate and decidedly slanted article about a member of SC life sciences see more

    South Carolina is blessed with over 1,000 life sciences organizations, engaged in biotechnology and pharmaceuticals to medical devices and health IT. Never was this more important than during the pandemic, when millions were hospitalized and too many lives lost.

    As neighbors fell ill, our industry -- including Charles River Laboratories professionals -- stepped up. Over 100 organizations produced PPE, tested for COVID-19, conducted vaccine clinical trials, and expedited health solutions. Gov. McMaster expressed appreciation by declaring Life Sciences Week in South Carolina.

    As our state’s voice of life sciences, SCBIO wishes your “Monkeys & Blood” article had highlighted Charles River’s globally celebrated work that helps save millions of lives and improves patient safety.

    Carefully obtained from Atlantic horseshoe crabs by Charles River professionals, Limulus amebocyte lysate (LAL) is critical to saving lives of patients everywhere. The unique, natural substance is used to test every injectable pharmaceutical, implantable medical device, and approved COVID-19 vaccine against contamination. Without it, endotoxins could enter the body and produce life-threatening sepsis.

    For decades, Charles River has protected and nurtured our crab population. Its microbial testing is considered best-in-class by scientists globally. And with synthetic LAL neither readily available nor FDA-licensed, industry experts decline its sole use because the safety of IVs, vaccines and more would not be assured as with natural LAL.

    Charles River and our life sciences ecosystem make tremendous contributions to our state and the health of mankind. Their lifesaving medical innovations should be celebrated.

    James Chappell, CEO of SCBIO

  • sam patrick posted an article
    SCBIO believes growing the life sciences sector will significantly transform the state’s economy. see more

    Compliments of the Community Journal...

    It was all smiles on Sept. 30 as BMW marked the 25th anniversary of the first vehicle to roll off its Spartanburg assembly line, a singular moment that dramatically transformed the economic face of South Carolina.

    A quarter-century after opening, the German manufacturer’s North American facility employs more than 11,000 workers who build 1,500 vehicles daily, a pace requiring the services of more than 40 main suppliers across the state.

    The average wage among all S.C. jobs supported by the automotive industry stood at $64,120 in 2017 compared to $40,293 across all employment categories, say findings commissioned by the South Carolina Biotechnology Industry Organization (SCBIO).

    Now three years old, SCBIO is spearheading an aggressive initiative to make South Carolina the preferred location for new or expanding companies in another highly promising industry: life sciences.  Read the entire story by clicking here.

  • sam patrick posted an article
    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.

  • sam patrick posted an article
    Charles River Labs quietly continues its critical work to save lives see more

    Compliments of the Associated Press

    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.”

  • sam patrick posted an article
    SCBIO, business community shaping curriculato grow life sciences careers see more

    Compliments of GSA Business and SCBIZ

    South Carolina’s life science sector creates twice as many jobs as the average of all other sectors in the state economy, according to a recent study, but whether it can fill those positions is another matter — especially in the manufacturing and logistics side of the house.

    The life science fields are struggling to fill positions in the fast-growing sector. (Photo/Provided)

    “It has historically been the majority of the time that you find a qualified person, they already have a job in M&L (manufacturing and logistics), so it has really been tough to fill the need,” said Josh Turner, a sales executive for Modjoul, a health-focused data analytics company that serves the manufacturing sector. Turner is also a former staffing professional.

     He added that staffing companies pre-pandemic were filling positions with available people even if they weren’t trained or had any experience in the field.

    “All I’ve heard since the pandemic is [that] it has been hard to even find available people, much less available and qualified people,” he said.

    This gap is even more prominent in a life science field that sometimes requires more than the standard specialization or training. And to add insult to injury, few in-school training programs target this unique brand of manufacturing and logistics, said SCBIO interim CEO Erin Ford.

    “The life sciences encompasses so many aspects from medical devices to pharmaceutical research and development to logistics in getting the drugs or pharmaceuticals or medical devices to where they need to be,” she said. “There's just so many aspects to the life sciences. And we really, as a state, have not focused on having any specific curriculum or programs that are specialized in this area.”

    She argued that while the traditional medical careers such as nursing fall under the Life Science umbrella, industrial aspects of the sector often get overlooked in the classroom.

    “It’s just not even a part of the discussion as to what career you want to have,” Ford said.

    Arthrex and Tri-County Tech have had an existing apprenticeship partnership since 2020. (Photo/Provided)

    Since the economic development organization formed its Workforce Development Taskforce a few years ago, its more than 300 members have aimed to do something about that.

    She hopes that 2021 (or early 2022) will be the year she can see their work come to fruition through a curriculum pilot geared toward two-year students in South Carolina’s technical college network.

    Students upon learning about the field may often feel intimidated by the math or science components attached to a traditional science, technology, engineering and math field, she said, but really it’s the requirements of working in a clean room in the medical device field that can prove to be the most challenging.

    And that is the gap Ford hopes the program will fill.

    So far, Tri-County Technical College, Trident Technical College, Greenville Technical College and Midlands Technical College have signed on to the pilot, she said, which covers a track for pharmaceutical or biotech professionals and those seeking a career in the medical device field.

    “We don't want to reinvent the wheel,” Ford said. “That's why we're working with a lot of the partners to add in more substance for life sciences. So if we see that there is more for us to do, we will definitely take that on.”

    Life science companies in each region have already offered up some input to their needs and will continue to do so once the program launches: Trident Technical College has its ear to the ground for workforce demands of AlcamiCharles River Labs and Vikor Scientific while Tri-County Technical College is partnering with ArthrexAbbott Laboratories and Poly-MedMidlands Tech has an open channel to the demands of medical device companies Rhythmlink and Nephron Pharmaceuticals.

    “You’ve seen the map, right? Of the 700 life science companies? The kids just don’t know,” she told GSA Business Report, adding that it’s the job of SCBIO and its partners to share the story of the state’s abundance of life science firms and manufacturers.

    Medical device manufacturer Poly-med CEO Dave Shalaby said his company usually hires Clemson University graduates and has a strong in-house program, but now that the hiring climate has become so competitive in the Upstate, he has started to advise Tri-County Tech on courses that would expose students to the industry’s ISO 1345 standards and documentation.

    “And really surprisingly, it's not really geared toward the sciences as much as it's geared toward control, like how to control processes and design, and also there's a lot of statistics involved with showing proof that you're adhering to specific specifications that you've set,” Shalaby said. “So basically the course outline that we set up with Tri-County is to give them exposure to those sorts of things.”

    Tri-County instructors will teach company and industry requirements, he said, and help create a workforce pipeline to Poly-med, Arthrex and Abbott.

    “Tri-County is developing that curriculum now,” he said. “They’ve got sort of a draft in place, and it’s got to come back out for everybody to take a look at it and see if it makes sense to create the course.”

    The course would help prime students for employment at partnering industries like Poly-med, and Ford foresees a potential apprenticeship route on a case-by-case basis. SCBIO has been in conversation with Apprenticeship Carolina’s Carla Whitlock on those possibilities.

    In the meantime, Ford encouraged other industry voices interested in contributing to the program through input or partnership to get in touch and jump on board.

    “Reach out to us,” she said. “Reach out to me and SCBIO, because the more industry that we can have involved in these programs, the more successful it will be.”

  • sam patrick posted an article
    SCBIO, technical colleges stepping up for life sciences see more

    Compliments of GSA Business and SCBIZ News

    South Carolina’s life science sector creates twice as many jobs as the average of all other sectors in the state economy, according to a recent study, but whether it can fill those positions is another matter — especially in the manufacturing and logistics side of the house.

    “It has historically been the majority of the time that you find a qualified person, they already have a job in M&L (manufacturing and logistics), so it has really been tough to fill the need,” said Josh Turner, a sales executive for Modjoul, a health-focused data analytics company that serves the manufacturing sector. Turner is also a former staffing professional.

    He added that staffing companies pre-pandemic were filling positions with available people even if they weren’t trained or had any experience in the field.

    “All I’ve heard since the pandemic is [that] it has been hard to even find available people, much less available and qualified people,” he said.

    This gap is even more prominent in a life science field that sometimes requires more than the standard specialization or training. And to add insult to injury, few in-school training programs target this unique brand of manufacturing and logistics, said SCBIO interim CEO Erin Ford.

    “The life sciences encompasses so many aspects from medical devices to pharmaceutical research and development to logistics in getting the drugs or pharmaceuticals or medical devices to where they need to be,” she said. “There's just so many aspects to the life sciences. And we really, as a state, have not focused on having any specific curriculum or programs that are specialized in this area.”

    She argued that while the traditional medical careers such as nursing fall under the Life Science umbrella, industrial aspects of the sector often get overlooked in the classroom.

    “It’s just not even a part of the discussion as to what career you want to have,” Ford said.

    Since the economic development organization formed its Workforce Development Taskforce a few years ago, its more than 300 members have aimed to do something about that.

    She hopes that 2021 (or early 2022) will be the year she can see their work come to fruition through a curriculum pilot geared toward two-year students in South Carolina’s technical college network.

    Students upon learning about the field may often feel intimidated by the math or science components attached to a traditional science, technology, engineering and math field, she said, but really it’s the requirements of working in a clean room in the medical device field that can prove to be the most challenging.

    And that is the gap Ford hopes the program will fill.

    So far, Tri-County Technical College, Trident Technical College, Greenville Technical College and Midlands Technical College have signed on to the pilot, she said, which covers a track for pharmaceutical or biotech professionals and those seeking a career in the medical device field.

    “We don't want to reinvent the wheel,” Ford said. “That's why we're working with a lot of the partners to add in more substance for life sciences. So if we see that there is more for us to do, we will definitely take that on.”

    Life science companies in each region have already offered up some input to their needs and will continue to do so once the program launches: Trident Technical College has its ear to the ground for workforce demands of AlcamiCharles River Labs and Vikor Scientific while Tri-County Technical College is partnering with ArthrexAbbott Laboratories and Poly-MedMidlands Tech has an open channel to the demands of medical device companies Rhythmlink and Nephron Pharmaceuticals.

    “You’ve seen the map, right? Of the 700 life science companies? The kids just don’t know,” she told GSA Business Report, adding that it’s the job of SCBIO and its partners to share the story of the state’s abundance of life science firms and manufacturers.

    Medical device manufacturer Poly-med CEO Dave Shalaby said his company usually hires Clemson University graduates and has a strong in-house program, but now that the hiring climate has become so competitive in the Upstate, he has started to advise Tri-County Tech on courses that would expose students to the industry’s ISO 1345 standards and documentation.

    “And really surprisingly, it's not really geared toward the sciences as much as it's geared toward control, like how to control processes and design, and also there's a lot of statistics involved with showing proof that you're adhering to specific specifications that you've set,” Shalaby said. “So basically the course outline that we set up with Tri-County is to give them exposure to those sorts of things.”

    Tri-County instructors will teach company and industry requirements, he said, and help create a workforce pipeline to Poly-med, Arthrex and Abbott.

    “Tri-County is developing that curriculum now,” he said. “They’ve got sort of a draft in place, and it’s got to come back out for everybody to take a look at it and see if it makes sense to create the course.”

    The course would help prime students for employment at partnering industries like Poly-med, and Ford foresees a potential apprenticeship route on a case-by-case basis. SCBIO has been in conversation with Apprenticeship Carolina’s Carla Whitlock on those possibilities.

    In the meantime, Ford encouraged other industry voices interested in contributing to the program through input or partnership to get in touch and jump on board.

    “Reach out to us,” she said. “Reach out to me and SCBIO, because the more industry that we can have involved in these programs, the more successful it will be.”

  • sam patrick posted an article
    Many major life science firms have made the move to the Charleston region, and more are on the way see more

    Compliments of Industry Today

    December 19, 2019

    Charleston leads the nation for job growth in scientific R&D firms. In the past two decades, major life science firms have made the move to the Charleston region. Charleston is home to 75+ medical device and pharmaceutical manufacturers, research laboratories and service companies. Life science executives across the globe are discovering that the Charleston region offers what many other larger, oversaturated markets cannot: a lifestyle that attracts and retains top talent, easy connections to life science and healthcare executives, and business-friendly regional and state support.

    Read the full article HERE.