South Carolina economic development

  • sam patrick posted an article
    $30.2 million investment will create 425 new jobs see more

    Pall Corporation (Pall), a global leader in filtration, separation and purification, today announced plans to establish operations in Spartanburg County. The company is creating 425 new jobs and investing $30.2 million into a new facility that will support the rapid development and production of vaccines and therapeutics, including a COVID-19 vaccine.

    Pall serves the needs of customers across the broad spectrum of life sciences and industry and works with clients around the world to advance health, safety and environmentally responsible technologies.

    Located at 816 Berry Shoals Road in Duncan, Pall's new facility will focus primarily on single-use technology such as the Allegro™single-use platform.

    The facility is expected to be operational in May 2021. Individuals interested in joining the Pall team should visit the company's careers webpage.

    The Coordinating Council for Economic Development has approved job development credits related to the project.

    QUOTES

    "Spartanburg County provides Pall with the diverse workforce we need to manufacture life-saving therapeutics and vaccines. We look forward to building our presence in this county." -Pall Life Sciences President Joseph Repp

    "Pall Corporation's decision to invest into South Carolina comes at a time when our life sciences sector has evolved into one of our fastest-growing industries. The continued development of life sciences will create high-paying jobs that will ensure wellness and prosperity in South Carolina for years to come." -Gov. Henry McMaster

    "We could not be happier with Pall Corporation's decision to invest in Spartanburg County. We welcome this globally recognized company to South Carolina, and we look forward to partnering with them going forward." -Secretary of Commerce Bobby Hitt

    "The decision by Pall Corporation to come to Spartanburg is a win for our county, and a win for our budding life sciences sector. The variety of investments coming into our county, and the diversity of the industries that now call Spartanburg home, is a sign that our future is bright in the years to come." -Spartanburg County Councilman and Chairman of the Economic Development Committee David Britt

  • sam patrick posted an article
    Study shows diagnostic test effective for providing conclusive genetic results see more

    GREENWOOD, SC – The Greenwood Genetic Center (GGC), working with collaborators at Lawson Health Research Institute in Canada and the University of Amsterdam, published a study this month that provides clinical validation of EpiSign, a molecular genomics test that diagnoses rare, heritable neurodevelopmental conditions. GGC has been the sole US laboratory provider of this novel diagnostic test since 2019.

    EpiSign analyzes changes that affect gene expression rather than the gene sequence. Researchers have found that certain genetic disorders display unique genomic patterns, or epigenetic signatures, allowing for a diagnosis through EpiSign when traditional genetic testing has been uninformative.

    The laboratory testing in the US is performed at GGC while the analysis of the results is performed using machine learning at Lawson where the EpiSign Knowledge Database was developed. This database compiles information on rare genetic diseases using laboratory analyses of the epigenetic signature from patients with suspected genetic abnormalities.

    The current study analyzed data from early EpiSign testing to validate the ability of the novel test to make a diagnosis. Epigenetic signatures have been identified for over 40 genetic disorders.

    The analysis studied EpiSign test performance and diagnostic yield in 207 subjects from two different cohorts. A targeted group included patients with previous genetic findings that were ambiguous or inconclusive. The second screening group was those with clinical findings consistent with hereditary neurodevelopment syndromes but with no previous genetic findings.

    “Of the 207 subjects tested, 57 were positive for a diagnostic episignature including 48 in the targeted cohort, and 9 in the screening cohort. Only four remained inconclusive after EpiSign analysis,” says Dr. Bekim Sadikovic, lead researcher at Lawson and Scientific and Clinical Director of the Verspeeten Clinical Genome Centre at London Health Sciences Centre (LHSC). “This gives us strong evidence for the clinical use of EpiSign, as well as the ability to provide conclusive findings in the majority of subjects tested.”

    While currently there are limited treatment options associated with many of these conditions, providing a diagnosis can help physicians better predict the course of the disease, and allows for better planning and support for the patient. EpiSign is the only test in the world that has been clinically validated for epigenetic testing for these types of genetic disorders, and in the US, is only available through GGC.

    “Patients with rare diseases often wait years and undergo numerous exams and tests before receiving a correct diagnosis, if one is found at all,” says Matthew Tedder, PhD, staff scientist at the Greenwood Genetic Center, who was involved in the study. “EpiSign provides an additional high-yield diagnostic tool for clinicians to include in their evaluation of patients with undiagnosed diseases, providing better medical management for patients and hope for their families.”

    The study, “Clinical epigenomics: genome-wide DNA methylation analysis for the diagnosis of Mendelian disorders", is published in February’s Genetics in Medicine.

    For more information about EpiSign, visit, www.ggc.org/EpiSign.

  • sam patrick posted an article
    Executive Partnering, Virtual Exhibit Hall Add Draw for Power of Us Conference Feb. 16-17 see more

    With conference registration surging more than 20% past prior record levels and the addition of a “singularly significant innovation announcement focused on cancer treatments and precision medicine advancement”, SCBIO's “The Power of Us”  virtual conference Feb. 16-17 is preparing for its largest gathering ever next week... delivered virtually to registrants from across the Palmetto State plus 25 states and 8 countries.

    Adding to the excitement is a just-scheduled “major innovation announcement” by a South Carolina company, in tandem with West Coast and German allies, that has significant implications for cancer diagnosis and treatment on a global level, organizers say.

    Already in excess of 500 registrants from across America and around the globe, the acclaimed SCBIO conference – the annual gathering of South Carolina’s life sciences community – will also celebrate the rapid growth of the industry and the contributions of its 800+ organizations in helping America and the world overcome the brutal COVID-19 pandemic.

    South Carolina life sciences has seen a doubling of firms and 40% increase in life sciences’ direct employment since 2017, which combine to make it the fastest growing industry sector in the state, according to recent data provided by Dr. Joseph Von Nessen, the state's research economist and noted economic development expert with the Moore School of Business at the University of South Carolina.

    “Dr. Von Nessen’s data validates that the life sciences industry in South Carolina is experiencing stunning growth, thanks to the combined efforts of our state’s economic development teams, industry partners, research universities, elected officials and other partners,” said SCBIO CEO Sam Konduros.  “It’s an exciting time to be a part of an industry that is saving lives and improving quality of care.”

    The industry has a $12+ billion economic impact in the Palmetto State, with more than 800 firms located in 42 of 46 counties across the state and over 43,000 professionals employed directly or indirectly in research, development and commercialization of innovative healthcare, medical device, industrial, environmental and agricultural biotechnology products.

    Organizers are tight-lipped about the Innovation Announcement details, which will be unveiled at 8:30 a.m. on the second day of the conference—February 17. 

    “We will say that the implications of the announcement include a new technology that has the ability to detect cancers at the earliest time ever, to further lifespans, and to unlock a new era of precision medicine, ” said Mr. Konduros.

    Adding to the draw of the conference are scores of organizations from across America showcasing their capabilities in a virtual exhibit hall, direct 1-to-1 executive meetings on demand via a Partnering Portal, major industry awards and – naturally – top speakers.

    Committed presenters include BIO Global CEO Dr. Michelle McMurry-Heath; Microsoft Vice President Jamie Harper, who leads the global team supporting higher education and K-12 initiatives; and Bill Stadtlander, Commercial Leader of Verily, the Google subsidiary focused on life sciences and use of health data and AI to improve lives.

    Also speaking at SCBIO 2021 are Courtney Christian, Senior Director of Policy and Research at PhRMA and former leader of the Black Women's Health Imperative; Dr. Harris Pastides, former USC President and outgoing chair of the SC Institute of Medicine and Public Health; Dr. Pat Cawley, CEO of MUSC Health; and Dr. Marjorie Jenkins, Dean of the USC School of Medicine - Upstate and Chief Academic Officer of Prisma Health Upstate, among others.

    Themed “The Power of Us,” the 2-day SCBIO 2021 virtual event will feature sessions on The Power of Innovation, The Power of Partnership, and The Power of People – each a fundamental force which drives the state’s surging $12 billion industry that is a key contributor to South Carolina’s expanding knowledge economy.

    The conference will also feature SCBIO CEO Sam Konduros delivering the “State of South Carolina’s Life Sciences Industry” address, and release of SCBIO’s 2020 annual report

    Leaders already registered to attend include executives from Presenting Sponsor Vikor Scientific, Champion Sponsor Nephron Pharmaceuticals, Keynote Sponsor Medpoint, Pinnacle Awards Sponsor Softbox and others.  Leading biotech and med-tech industry brands participating include BIO, Johnson & Johnson, AVX, PhRMA, AdvaMed, Poly-Med, VWR, Ritedose Corporation, Rhythmlink, ZEUS, Patheon Thermo Fisher, Zverse, Abbott, Alcami, SSOE – Stevens & Wilkinson, and more.  All of South Carolina’s research universities – MUSC, Clemson and the University of South Carolina – are represented, as are major healthcare systems, the South Carolina Department of Commerce, SCRA, South Carolina Hospital Association and others.

    Registration is open online at the 2021 Virtual Conference section of www.scbio.org.  Registration is free to employees of most SCBIO investors and supporters as well as to students interested in life sciences careers, while faculty and teachers can attend the entire conference for $25.  General admission tickets are available for as little as $75.  Virtual Exhibit  space and sponsorships are also available by inquiring at info@scbio.org.

    For additional information on SCBIO or to register for SCBIO 2021, visit www.SCBIO.org.

  • sam patrick posted an article
    Founders take virtual stage at South Carolina life sciences conference to introduce technology see more

    Founders take virtual stage at South Carolina life sciences conference to introduce revolutionary ability for early detection of cancer mutations

     

    Santa Monica, CA and Charleston, SC -- Feb. 17, 2021Vikor Scientific, a South Carolina-based leading, molecular diagnostics company with a rapidly expanding nationwide footprint, has announced a strategic investment in California-based Quantgene Inc. to accelerate the commercialization of Quantgene’s flagship product, SerenityTM. Serenity provides world-leading accuracy in precision genomics and AI-enabled personalized preventative care.

    Quantgene’s Serenity combines advanced next-generation sequencing with proprietary cloud and AI technology to uncover deeper and more meaningful health insights earlier. Serenity will launch with four core components of health protection:

    • Liquid biopsy to detect cancer-related mutations in the blood to support early detection
    • Deep genomic sequencing across all 20,000 genes for a more complete picture of disease, medication and lifestyle risks
    • In-depth patient health profiles including health history, family history and lifestyle to bring more context to test results
    • An expert clinical team to provide analysis and connect patients to a network of world-leading medical experts

     

    The combination of these components allow the system to detect, flag and monitor disease and disease risk at earlier stages. Early intervention for potentially fatal conditions like cancer is critical to ensuring better treatment response and long-term outcomes. This is a critical advancement in marrying medicine and technology to ensure the company realizes their mission of extending the average lifespan of members by a decade within a decade.

    South Carolina-based Vikor Scientific is a market leader in providing targeted, molecular diagnostics that can improve clinical and economic outcomes.  Headquartered in Charleston, S.C., Vikor anchors the WestEdge Life Sciences Campus adjacent to the Medical University of South Carolina and is approaching 400 employees nationwide.  The announcement was made at SCBIO 2021, the acclaimed national conference of South Carolina’s life sciences industry which draws industry leaders from around the globe.

    In addition to ensuring the successful launch of Serenity commercially, the new partners have plans to launch several downstream liquid biopsy-based clinical oncology products including minimum residual disease detection (“MRD”), recurrence monitoring and companion diagnostics over the next several months. Vikor Scientific will leverage their proven commercialization engine for innovative molecular diagnostics technologies and leverage their growing national salesforce in service of the new product roll outs.

    Shea Harrelson, co-founder of Vikor Scientific, said: “In Quantgene, Vikor saw a compelling opportunity to support the commercialization of advanced genomics in the service of preventative care and positively impacting the course of many chronic diseases, starting with cancer. This partnership aligns perfectly with our mission as a company - to improve patient outcomes and prevent unnecessary healthcare costs and delays in treatment by improving diagnostic accuracy, reducing turnaround time and personalizing treatment options.”

    Scotty Branch, co-founder of Vikor Scientific added: “Changing the paradigm of healthcare has always been the vision for Vikor Scientific. The platform built by the Quantgene team is revolutionary and certain to accelerate the speed at which we diagnose and treat patients for cancer. Vikor is excited to lead the commercialization and expand on our mission of driving clinical outcomes. And we are particularly excited to do so here in Charleston, where we envision a dynamic future for innovation, growth and expansion of the booming life sciences hub here in South Carolina.”

    “With Serenity, we are first-to-market in combining liquid biopsy cancer detection with whole exome sequencing and advanced medical intelligence. We hope to unlock a new era in medicine in which trained physicians can detect multiple cancers at early stages in the blood with single molecule precision.” added Jo Bhakdi, founder and CEO of Quantgene. “Serenity brings genomic technologies to patients within an innovative system of preventative care that we believe will set a new standard in patient-centered personalized medicine. We are excited to take this important step with our partners at Vikor Scientific.”

    Alluding to Serenity as a new frontier in science that “promises earlier detection than ever and promises to unlock a new era of medicine,” Branch saluted the role of SCBIO and the Charleston Regional Development Authority in making the announcement a reality.

    “I can envision the day when this collaboration leads to a new corporate hub here with new labs and bright new talent from South Carolina medical schools advancing this revolutionary technology,” Branch added.  “We credit the efforts of SCBIO and this state in bringing our organization and Quantgene together, and we intend to identify new collaborations and partnerships that advance the future of medicine, and promise a healthier future for our state, country and world.”

  • sam patrick posted an article
    SCBIO, industry honored by Governor during record-setting virtual annual conference see more

    South Carolina Gov. Henry McMaster

    Proclamation – Feb. 15, 2021

     

    WHEREAS, South Carolina has cultivated a cutting-edge life sciences sector with an annual economic impact of more than $12 billion dollars; and

    WHEREAS, more than 800 firms and over 43,000 professionals are directly involved in the research, development and commercialization of innovative healthcare, medical device, industrial, environmental and agricultural biotechnology products; and

    WHEREAS, since 2017, the life sciences sector has become South Carolina's fastest- growing industry, with employment growing at double the rate of South Carolina's economy as a whole; and

    WHEREAS, SCBIO is the organization exclusively focused on attracting new life science sector jobs and investment to South Carolina; and

    WHEREAS, during the COVID-19 pandemic, more than 100 life sciences organizations across South Carolina worked together to support and promote the procurement and distribution of personal protective equipment, support and implement COVID-19 testing and expedite health solutions for our citizens; and

    WHEREAS, in collaboration with the South Carolina Department of Commerce and SCBIO, South Carolina's economic development recruitment efforts shall include an enhanced emphasis and focus on attracting, building, advancing, innovating and growing existing and new life sciences businesses in the state.

    NOW, THEREFORE, I, Henry McMaster, Governor of the great State of South Carolina, do hereby proclaim February 15-19, 2021, as

    SCBIO LIFE SCIENCE WEEK

    throughout the state and encourage all South Carolinians to recognize and appreciate the many contributions of the life sciences industry to South Carolina's health and economic prosperity.

  • sam patrick posted an article
    Governor salutes industry during record-setting SC Life Sciences Conference see more

    SOUTH CAROLINA – February 16, 2021 – In recognition of the importance of the life sciences industry in South Carolina, Governor Henry McMaster today issued a proclamation recognizing February 15-19, 2021 as South Carolina Life Sciences Week in the Palmetto State.

    Governor McMaster made the announcement just steps from where SCBIO organizers were putting the finishing touches on Day 1 of the largest-ever life sciences gathering held – virtually of course -- in the state.  A record 600 registrants from across America and around the globe are attending the virtual SCBIO gathering of South Carolina’s life sciences community – and celebrating the contributions of its 800+ organizations in helping America and the world overcome the challenging COVID-19 pandemic.

    “South Carolina has developed a strong reputation as an emerging leader in the life sciences,” said Governor McMaster. “Our innovative companies and exceptional workforce are key drivers in strengthening our economy and creating new opportunities for South Carolinians. With an incredible pace of growth in the industry here, we know that the life sciences will continue to play a critically important role in our state’s economic success for generations to come.”

    Governor McMaster made the proclamation in downtown Greenville, in the heart of the county which possesses the state’s largest concentration of life sciences companies, although the industry boasts life sciences organizations in 42 of South Carolina’s 46 counties currently.  Governor McMaster was flanked by leadership and Board members of SCBIO, South Carolina’s investor-driven economic development organization exclusively focused on building, advancing, innovating and growing the life sciences industry in the state. 

    Life sciences has a $12 billion economic impact in the Palmetto State, with more than 800 firms involved and over 43,000 professionals employed in the research, development and commercialization of innovative healthcare, medical device, industrial, environmental and agricultural biotechnology products.  It also represents a significant economic development focus for the state, with strong life science recruiting initiatives led by the South Carolina Department of Commerce and other regional economic development teams.

    South Carolina life sciences has seen a doubling of firms and 40% increase in life sciences’ direct employment since 2017, which combine to make it the fastest growing industry sector in the state, according to recent data provided by Dr. Joseph Von Nessen, the state's research economist and noted economic development expert with the Moore School of Business at the University of South Carolina.

    “Life sciences is a major driver of South Carolina’s economy today, and this conference is testament to the industry’s surging impact, reach and rapidly rising economic significance in our state and country,” noted SCBIO President and CEO Sam Konduros. “We’re honored by Governor McMaster’s recognition, and appreciate his personal support for the contributions that life sciences are making to improve quality of life, care and economic standing for South Carolina citizens.”

    For additional information on SCBIO or to register for SCBIO 2021, visit www.SCBIO.org.

  • sam patrick posted an article
    Producing and shipping 10,000 Rapid COVID-19 antigen test kits for King of Hammers racing event see more

    Vigilent Labs​, an advanced health and medical technology company that provides solutions for the detection, identification and assessment of health and bio-threats, has completed and shipped its first major order of Alfa Scientific Instant-View COVID-19 Antigen Test Kits for use in the King of Hammers racing event. 

    ”We have worked diligently for months to progressively and proactively execute the safest off-road racing event possible, and we could not have held this event without the help of Vigilent Labs,” said Dave Cole, Lead for the King of Hammers Race and President of Hammerking Productions. "Our innovative partnership with Vigilent Labs enabled us to navigate public health requirements and deploy a comprehensive digital COVID monitoring solution for pre-screening our racing event attendees to ensure their health and safety." 

    This project marks an important milestone for Vigilent Labs and the South Carolina life science sector as the company recently announced that it is investing more than $104.6 million and will create over 400 new jobs at its state-of-the-art COVID-19 test manufacturing facility in the Charleston Navy Yard. 

    "Our Vigilent Labs Medical Systems technology platform is the first digital health credential connecting a real person to a rapid COVID test, taking health surveillance to the Next Level​,​” said John Falk, President of Vigilent Labs. “With the outstanding support from the entire FedEx organization, we were able to quickly get these important COVID-19 test kits into the hands of the King of Hammers organizers, enabling their public event to go forward in California."

    The cost-effective rapid antigen tests, which produce fast and accurate results in seven to 10 minutes, are CE-marked and pursuant to CDC guidance, useful for COVID-19 screening and surveillance. The kits will be immediately put to use by the​ ​King of Hammers Racing​ event, which is being held from January 28 to February 6, 2021, in San Bernardino County, California, to pre-screen attendees for COVID-19. This event is the first widely attended event to deploy the Vigilent Labs’ v.PASS digital credential, the company’s state-of-the-art ​health monitoring solution​, to ensure adherence to​ ​increased federal, state and local safety guidelines​. 

    “We take pride in our dependable, fast and efficient transportation mechanisms, which enabled us to help Vigilent Labs to deliver these COVID-19 antigen tests,” said Elizabeth Tonelis, FedEx Sales Executive. 

    To learn more about Vigilent Labs’ solutions for COVID-19 testing and monitoring, visit www.vigilentlabs.com​. 


    About Vigilent Labs 
    Vigilent Labs is an advanced health and medical technology company that provides solutions for the detection, identification and assessment of health and bio-threats. The company provides point-of-care (POC) medical testing devices, initially centered on the COVID-19 pandemic, paired with a comprehensive digital health and credentialing platform that offers near real-time tracking of disease. Founded in 2019, Vigilent Labs is headquartered in Charleston, South Carolina, with additional manufacturing and production facilities in Laramie, Wyoming and throughout the United States. For more information, visit ​https://vigilentlabs.com/​. 

     

  • sam patrick posted an article
    Nephron, Lexington County businesses step up again see more

    Compliments of Post and Courier Columbia

    WEST COLUMBIA — Nephron Pharmaceuticals CEO Lou Kennedy watched proudly from her office window as a company security guard rushed out to help a woman with a hot pink walker from her vehicle into the West Columbia drug company’s headquarters. 

    Having found the location on the state Department of Health and Environmental Control’s website, the woman was there to receive a COVID-19 vaccine.

    Nephron, along with Cayce-based Dominion Energy and two Lexington County road sign companies, Stay Alert Safety Services and Optec Displays, are donating time and services to put on a free drive-thru vaccine clinic. Eligible participants, age 65 or older, must have an appointment to receive a shot.

    “I’m so proud we can do this,” Kennedy said.

    While the vaccine itself is free, providers are legally able to bill people or their insurance for the doctor or pharmacy visit. Nephron is not charging.

    With about 30 nurses on staff and almost as many doctors of pharmacy, the West Columbia drug maker applied for the certification needed to give the shots and administered its first 500 doses to Lexington County seniors inside its building over the week of Feb. 1.

    It has 1,000 more doses to start giving out on Feb. 8, this time without people having to get out of their vehicles in an effort to make recipients more comfortable, Kennedy said.

    When she first had the idea, she called Keller Kissam, president of electric operations at Dominion Energy South Carolina, to ask if they could use the power company’s vehicle turnaround area. Dominion’s headquarters a 10-minute drive from Nephron.

    “Keller didn’t even hesitate,” Kennedy said. “It was ‘What can we do? How do we help?’ You talk about community spirit.”

    In addition to the drive-thru space, Dominion is providing power to the site to power the computers needed to make appointments for recipients’ second doses. Stay Alert, Optec, as well as the town and county of Lexington are providing signage.

    Those wishing to receive a vaccine from Nephron can go online to DHEC’s website in order to sign up for an appointment.

  • sam patrick posted an article
    Robotics usage expands at Nephron see more

    Two years ago, Nephron Pharmaceuticals brought a problem to the engineering and pharmacy colleges at the University of South Carolina.

    When employees operating machinery at Nephron called in sick or otherwise couldn’t come to work, production is halted. Nephron CEO Lou Kennedy hoped the company and the two colleges could find a solution.

    Kennedy is no stranger to the university, having graduated from USC. She and her husband Bill also established the Kennedy Pharmacy Innovation Center in conjunction with the USC School of Pharmacy.

    However, she had not been a part of a collaboration with the university that actually shifted the way the West Columbia drug manufacturer operates.

    After several classes of mechanical engineering students and pharmacy students worked to fix the problem, the project was finally completed this year— a robot named Smithers after The Simpsons character. The robot improves productivity by cutting out most of the human involvement in pre-filling sterile syringes with injectable medicines.

    While Nephron has faster robots than Smithers, they require more human intervention.

    “It just continues to make drugs without, frankly, a bathroom break or other things. So a steady machine, even if it’s slower, is better than people who haven’t shown up for the night and we have orders to fill,” Kennedy said.

    Despite increased automation, Kennedy said employment will not be hurt. Nephron is currently in a hiring surge, trying to fill 380 positions including sterile pharmacy technicians and automation engineers. This year, Nephron will open its state-of-the-art vaccine production facility as part of a $215 million expansion.

    “I can’t hire enough sterile pharmacy techs for what I need fast enough because of our growth, so this is just augmenting what we’re already doing— not to replace humans,” Kennedy said.

    The robot consists of four pieces of equipment, all designed by students, that work together to mimic the actions of a human pre-filling sterile syringes, according to Nephron’s chief of engineering and USC mechanical engineering professor Ramy Harik. Separate pieces pick up the syringes, complete the filling process and cap the syringes to seal them.

    Harik led three different teams of senior engineering students over two years to create the robot, while pharmacy students made sure the medical and sterilization aspects of the robot was safe for future human injection. The teams tested nearly ten different designs before finding one that worked.

    The machine, which was installed last week, is being validated for commercial use and should be up and running in a couple of weeks, said Kennedy. She has already ordered the parts to make another one to put into production and hopes to have several of them going at the same time one day.

    “My dream for the university is that we could commercially market these robots for hospitals around the world,” said Kennedy. “If we had the ultimate dream, it would be to sell these and a portion of the proceeds go back to the pharmacy and engineering school and allow us to endow a scholarship for future research.”

    From the partnership, Harik created a pharmaceutical manufacturing class at USC for the next semester, and Nephron donated the equipment needed for students in the form of a glass cleanroom. The room allows students to work in a sterile environment for pharmacy manufacturing.

    “Usually an entry-level engineer wouldn’t be given the opportunity to build an entire system from the ground up and it’s just been a great opportunity,” said John Diamond, one of the engineering students who started the project and now works at Nephron.

  • sam patrick posted an article
    Enzyme and protein biotech leader creates, manufactures, distributes next gen products see more

    IRMO, S.C.  -- January 26, 2021 -- Integrated Micro-Chromatography Systems, Inc. (IMCS), known for their expertise in developing recombinant proteins and enzymes, has been awarded a $900,000 Small Business Innovation Research (SBIR) Fast-Track grant from the National Institutes of Health (Developing Chemoenzymatic Strategies, Enzymes, and Kits for Accessible and Affordable Gangliosides).

    Under this grant, IMCS expands enzymes, reagents, and methods for animal component-free manufacturing of various gangliosides. This award funds research into the production of affordable gangliosides and kits that will enable researchers to establish the potential of ganglioside-based diagnostics and therapeutic interventions. The grant will be headed by L. Andrew Lee, Ph.D., co-founder and Chief Scientific Officer of IMCS in conjunction with Xi Chen, Ph.D., Professor at the Department of Chemistry, University of California, Davis.

    Gangliosides are biomolecules that contain sugars and a particular type of lipids, or ceramides. Analogous to biological antennae in cells, gangliosides are involved in critical roles across multiple biological processes, making them ideal for therapeutic applications. With this research grant, IMCS will provide the broader scientific community access to affordable reagents and tools to synthesize and modify various gangliosides, thereby enabling researchers to understand how these biomolecules affect neurological functions.

    Ronald Schnaar, Ph.D., Professor of Pharmacology at the Johns Hopkins University School of Medicine likened the grant’s approach to building Legos. Schnaar, who is not involved in the grant, said that the technology presented features a very flexible system that would allow scientists to use molecular building blocks called glycans, to create a library of various gangliosides that could be used for a wide variety of research applications. “If you give us the pieces to build the Lego [structure], we can generate the tools to study anything from cell activity to testing potential therapeutics. You can use this to build anything. You can build a mimetic library.”

    In addition to its portfolio of enzymes, IMCS provides technologies to pharmaceutical companies, academic medical centers, and contract research organizations to develop next-generation antibody and gene therapy technologies, such as those used to fight the COVID-19 pandemic.

    Research reported in this press release was supported by the National Institute of General Medical Sciences of the National Institutes of Health under Award Number R44GM139441. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

    About IMCS

    Integrated Micro-Chromatography Systems, Inc (IMCS) is a privately held biotechnology company that strives to address the growing needs of clinical and research laboratories through innovative technologies and custom solutions designed to increase testing efficiency. IMCS creates, manufactures, and distributes next-generation biotechnology products to clinical and forensic toxicology, academic research facilities, US Federal Government agencies, and health science companies in North America, Europe, and the Asia Pacific Region.

  • sam patrick posted an article
    Registrations Surge, Partnering and Virtual Exhibit Hall Draw Strong Interest see more

    A newly announced group of national and state leaders will join Biotechnology Innovation Organization (BIO) President and CEO Dr. Michelle McMurry-Heath in headlining SCBIO's “The Power of Us”  virtual conference slated for broadcast Feb. 16-17.

    Newly announced additions include Microsoft Vice President Jamie Harper, who leads the global corporation's team supporting both higher education and K-12 initiatives across America, and Bill Stadtlander, Commercial Leader of Verily, the Google subsidiary focused on life sciences and use of health data and AI to improve lives.

    At Microsoft, Mr. Harper leads a team that supports higher education and K-12 initiatives impacting students, teachers, and leaders both public and private.  He previously has led Microsoft's US Education team and served as the General Manager of ten countries in Asia and South Africa.  Prior to Microsoft, Jamie worked for The Coca-Cola Company and Westinghouse Power Generation.  He holds an MBA from Emory University, and a degree in Industrial Engineering with a minor in Economics from Clemson University.

    Mr. Stadtlander is the Commercial Lead at Verily for Baseline, its end-to-end digital platform solution to transform clinical research by increasing participation, driving efficiency and incorporating novel data. Bill has over 15 years of commercial healthcare experience with prior roles at Ceribell, Element Science, Boston Scientific and McKinsey & Co.'s healthcare practice. He holds an MBA from Wharton, a Master of Biotechnology from University of Pennsylvania, and Mechanical and Biomedical Engineering degrees from MIT.

    Also named to speak at SCBIO 2021 are Courtney Christian, Senior Director of Policy and Research at PhRMA and former leader of the Black Women's Health Imperative; Dr. Harris Pastides, former USC President and outgoing chair of the SC Institute of Medicine and Public Health; Dr. Pat Cawley, CEO of MUSC Health; and Dr. Marjorie Jenkins, Dean of the USC School of Medicine - Upstate and Chief Academic Officer of Prisma Health Upstate, among other speakers.

    Themed “The Power of Us,” the 2-day SCBIO 2021 virtual event will feature sessions on The Power of Innovation, The Power of Partnership, and The Power of People – each a fundamental force which drives the state’s surging $12 billion industry that is a key contributor to South Carolina’s expanding knowledge economy.

    The conference will feature a virtual exhibit hall showcasing scores of life sciences industry organizations from across the country, and presentation of the prestigious Pinnacle Awards by South Carolina Life Sciences to the outstanding 2020 Organization of the Year and Individual of the Year.  SCBIO CEO Sam Konduros will deliver the “State of South Carolina’s Life Sciences Industry” address, while attendees can schedule 1-to-1 meetings with top executives through the conference’s Partnering Portal

    Hundreds of life sciences leaders from across the nation are already registered to attend with hundreds more expected.  SCBIO's virtual conference is supported by Presenting Sponsor Vikor Scientific, Champion Sponsor Nephron Pharmaceuticals, Keynote Sponsor Medpoint and others.  Among leading biotech and med-tech industry brands participating are Nephron, Vikor, BIO, Johnson & Johnson, AVX, PhRMA, Medpoint, AdvaMed, Poly-Med, VWR, Ritedose Corporation, Rhythmlink, SoftBox Systems, ZEUS, Patheon Thermo Fisher, Zverse, Abbott, Alcami and more.  All of South Carolina’s research universities – MUSC, Clemson and the University of South Carolina – are represented, as are major healthcare systems, and entities including the South Carolina Department of Commerce, SCRA, South Carolina Hospital Association and others.

    Registration is open online at the 2021 Virtual Conference section of www.scbio.org.  Registration is free to employees of most SCBIO investors and supporters as well as to students interested in life sciences careers, while faculty and teachers can attend the entire conference for $25.  General admission tickets are available for as little as $75.  Virtual Exhibit  space and sponsorships are also available by inquiring at info@scbio.org.

    SCBIO is South Carolina’s investor-driven economic development organization exclusively focused on building, advancing, and growing the life sciences industry in the state.  The industry has a $12 billion economic impact in the Palmetto State, with more than 750 firms directly involved and over 43,000 professionals employed directly or indirectly in the research, development and commercialization of innovative healthcare, medical device, industrial, environmental and agricultural biotechnology products.

    For additional information on SCBIO or to register for SCBIO 2021, visit www.SCBIO.org.

  • sam patrick posted an article
    HITRUST CSF Certification validates ChartSpan see more

    HITRUST CSF Certification validates ChartSpan, the industry’s largest provider of Chronic Care programs, is committed to meeting compliance regulations and protecting sensitive information.

    Greenville, SC – ChartSpan, a leading provider of turnkey Chronic Care Management (CCM) and Annual Wellness Visit solutions, today announced their CCM platform, RapidAWV™ application, and Data Integration services have earned Certified status for information security by HITRUST®.

    HITRUST CSF Certified status demonstrates that the organization’s CCM platform, RapidAWV™ application, and Data Integration have met key regulations and industry-defined requirements and are appropriately managing risk. This achievement places ChartSpan Medical Technologies in an elite group of organizations worldwide that have earned this certification. By including federal and state regulations, standards, and frameworks, and incorporating a risk-based approach, the HITRUST CSF helps organizations address these challenges through a comprehensive and flexible framework of prescriptive and scalable security controls.

    David Lowry, Chief Technology Officer at ChartSpan, expressed his pleasure with the achievement: “The HITRUST CSF Certification process has allowed us to mature our security and privacy postures as well as instill customer confidence in these processes. We appreciate the opportunity to validate that ChartSpan prioritizes the safety of our clients’ and patients’ data.”

    “HITRUST is helping organizations ensure that the highest standards of information protection requirements are met when sensitive data is accessed or stored,” stated Jeremy Huval, Chief Compliance Officer, HITRUST. “ChartSpan can be recognized as an organization that can be counted on for keeping information safe.”

    About ChartSpan Medical Technologies

    ChartSpan is the largest, managed service provider of chronic care management programs in the United States. The company provides turn-key, managed care coordination and compliance programs for doctors, clinics, and health systems. ChartSpan manages patient care coordination and value-based programs for more than 100 of the most successful practices and health systems in the United States.

  • sam patrick posted an article
    Softbox Systems the partner of choice for Pfizer vaccine see more

    Compliments of GSA Business Report and SCBIZ News

    Frontline workers at Prisma Health received the first shipment of Pfizer’s COVID-19 vaccine last week, but to some extent, the shipment was simply returning home to the Upstate.

    Greenville is the North American headquarters for Softbox, the British manufacturer of the insulated containers critical to the stability of the Pfizer vaccine.

    “I consider this the start to the finish as we move into this process of trying to get enough immunity into the community,” Dr. Steve Shelton said as the dry ice-laden Softbox made a triumphant arrival at Prisma Health-Midlands, complete with pom-poms and cheering health care workers. Shelton is an emergency room physician with Prisma Health who spearheaded COVID-19 treatment efforts in the Midlands.

    “I know there is a lot of anxiety about this, but I am confident in the FDA in making sure that they have approved an effective vaccine,” he said. “I feel like I am honored to be here to receive this and am doing my part to combat this disease.”

    To remain effective, the vaccine must be shipped at temperatures colder than most of Antarctica, in a box with more layers than a Russian doll. The Softbox includes a top layer or “pod” of dry ice housed on top of five trays of the vaccine, which in turn, nests in a carrying box with a foam lid and temperature gauge. All this is fitted in a cardboard shipping container, according to a Dec. 3 manual from Pfizer.

    Read the entire story here...

  • sam patrick posted an article
    Company Excited to Expand Generic Portfolio see more

    WEST COLUMBIA, S.C. – Nephron Pharmaceuticals Corporation is celebrating another milestone.

    The company today announced Food and Drug Administration (FDA) approval of the Nephron Abbreviated New Drug Application (ANDA) for Ketorolac Tromethamine Injection USP, 60 mg/2 mL (30 mg/mL) in Single-Dose Vials. The vials are made of polypropylene plastic with a “luer lock” interface for needle-free dosing and are manufactured using Blow-Fill-Seal (BFS) technology.

    Ketorolac Tromethamine becomes one of the first ANDA-approved non-respiratory generic medications produced by Nephron, signaling a new phase of company growth. Nephron secured FDA approval for Sodium Chloride IV Bags earlier this year.

    “We are extraordinarily excited to expand our generic medication portfolio to include non-respiratory products,” said Nephron CEO Lou Kennedy. “This is the latest sign that Nephron is growing, and it represents a real reason for our entire team to celebrate.”

    Nephron-manufactured Ketorolac Tromethamine is an injectable medication for the short-term treatment (up to 5 days) of moderately severe acute pain. Commonly used after surgeries and other medical procedures, Ketorolac Tromethamine is a nonsteroidal anti-inflammatory drug (NSAID).

    A West Columbia, S.C.-based company, Nephron develops and produces safe, affordable generic inhalation solutions and suspension products.

    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 their drug shortage needs. The company recently opened a CLIA-certified diagnostics lab and conducts COVID-19 tests for people across South Carolina.

    Prescribing information for Ketorolac Tromethamine Injection Vial UPS, 60 mg/2 mL (30 mg/mL) is available on the product package insert. More product information regarding Ketorolac Tromethamine Injection USP, 60 mg/2 mL (30 mg/mL) in Single-Dose Vials is available here

  • sam patrick posted an article
    South Carolina's Rhythmlink acquires California-based med device manufacturer see more

    COLUMBIA, SOUTH CAROLINA – Rhythmlink International, LLC is pleased to announce an exciting new investment, the acquisition of Chalgren Enterprises, a California-based medical device manufacturer that will add to their already extensive portfolio of products for brain and nervous system monitoring.  

    As a market leading designer and manufacturer of disposable neurodiagnostic devices and consumables, Rhythmlink has been quickly growing, even during an otherwise challenging year. Chalgren Enterprises provided another growth opportunity with a close alignment of culture, values, and product manufacturing expertise. The acquisition was completed on December 11, 2020. 

    “Chalgren is a good fit for our first acquisition both because of their experience in our industry and the way our cultures and missions align,” said Shawn Regan, CEO and Co-Founder of Rhythmlink. “Even with minimal changes we believe within the first year we’ll be able to take the Chalgren line of products and apply our manufacturing and sales best practices to see extensive growth.” 

    Chalgren Enterprises has been manufacturing electrodes for neurodiagnostics, specializing in EMG electrodes, for over 50 years. For the last 30 years Chalgren has been run by the father and son team of Richard and Michael Kaiser, who have seen the industry evolve from reusable to disposable products, product innovations, and a host of market and regulatory changes that have defined neurodiagnostic medical devices. Their reputation in the EMG market especially made them an appealing partner for Rhythmlink. 

    “Chalgren’s extensive experience is a good match for our innovation and steady growth,” said Regan. “Taking on their EMG products and legacy knowledge of EEG is a natural fit for our existing product lines and helps us encompass the full need of products that connect patients to machines.”

    With the acquisition of Chalgren, Rhythmlink International will now offer products for epilepsy monitoring, electroencephalography, electromyography, evoked potentials, polysomnography, intraoperative monitoring and more, better serving the needs of neurologists and critical care providers through one company. 

    Regan concluded, “The culture we have built at Rhythmlink and our reputation in the marketplace are incredibly important to us, and Chalgren comes to us with more similarities than differences. We wanted growth that would ensure this dynamic would stay intact, and we’re excited about the future of these products and our company.”

    About Rhythmlink
    Rhythmlink International is a medical device manufacturing company specializing in devices that help connect patients to machines to record or elicit physiologic information. Rhythmlink designs, manufactures and distributes a variety of medical devices for intraoperative neuromonitoring, electroencephalography, evoked potentials, polysomnography, long-term monitoring epilepsy and critical care units. Founded by neurodiagnostic technologists and engineers in 2002, Rhythmlink enhances patient care worldwide by transforming medical device technology that links patients to equipment. Rhythmlink also offers custom packaging, custom products, private labeling and contract manufacturing services.