Columbia College partners for better health see more
Eau Claire Cooperative Health Center (dba Cooperative Health) and Columbia College are pleased to announce a partnership to bring health care services to its campus and the local community starting Monday, March 22.
Columbia Community Family Practice will provide primary and preventative services for adult and pediatric patients, in addition to behavioral health counseling. The practice will be housed inside a 2,000 square foot-building on the Columbia College campus, located at 4808 Colonial Drive.
“We are excited to be partnering with Cooperative Health to provide much needed services to our own campus and also to the broader neighborhood community,” said Dr. Tom Bogart, president of Columbia College. “Cooperative Health is an important health provider in the Midlands. This partnership is an example of how we are able to collaborate and respond to key issues in our community.”
Columbia Community Family Practice will promote optimal wellness in campus and community members by removing socioeconomic barriers to care; enabling individuals to make informed health decisions; and empowering individuals to be self-directed consumers of their health care services.
“Cooperative Health is ecstatic to partner with Columbia College to bring a comprehensive health care facility to its campus. The presence of Columbia Community Medical Practice will improve the health of the student body and others within the 29203 community. We would like to thank the dynamic leadership of Columbia College for making this possible and welcoming us,” said Peatra Cruz, Chief Organizational Development and Communications Officer.
La’Kia Singleton, MSN, FNP-BC, will serve as the lead provider at the Columbia Community Family Practice. She brings more than a decade of experience as a family nurse practitioner with a specialty of treating acute and chronic health conditions for all ages.
An opening for Columbia Community Family Practice was held at the site on Friday, March 19. Due to the COVID-19 pandemic, the event was invitation only but was live streamed on Cooperative Health and Columbia College Facebook channels. Columbia Community Family Practice will operate Monday through Friday from 8:30 a.m. to 5:00 p.m. Call (803) 888-1106 to schedule an appointment.
About Eau Claire Cooperative Health Center (dba Cooperative Health)
Cooperative Health is a Federally Qualified Health Center (FQHC) and a Federal Tort Claims Act (FTCA) deemed facility. It operates as an independent non-profit organization providing primary care and preventative services with the aim of improving the health of patients on a community level. Cooperative Health offers comprehensive services including: family medicine, internal medicine, pediatrics, women’s health, behavioral medicine, dental, pharmacy, orthopedics and podiatry. In 2019, Cooperative Health provided health care services to more than 61,000 patients throughout the Midlands of South Carolina. It has a network of sites located throughout medically underserved areas in Richland, Lexington, Fairfield, and Newberry counties. Cooperative Health is recognized by the National Committee for Quality Assurance (NCQA) as a Patient Centered Medical Home.
About Columbia College
Columbia College was founded in 1854 as Columbia Female College by the Methodist Conference of South Carolina. Columbia College continues to serve as an institution for higher education with approximately 1,200 male and female students in both undergraduate and graduate courses.
Rutgers University and Premier Medical Laboratory Services Conduct Studies Showing TAG-NGPM+™ Inactivates SARS CoV-2 Virus, Increases StabilityTogether, Rutgers and Premier are publishing a scientific article demonstrating their findings see more
Public Health Research Institute at Rutgers New Jersey Medical School and Premier Medical Laboratory Services (PMLS) have conducted studies on the stability and viral inactivation properties of the Truckee Applied Genomics (TAG) TAG-NGPM+ virus inactivating media. The studies show that the non-flammable solution contains a chemical make-up which may increase both room temperature stability and freeze-thaw integrity. This means that the specimen is better preserved during transit to a testing laboratory, and as a result, could increase the accuracy of testing results while decreasing the number of samples ruined by temperature changes. Rutgers’ data also shows that the patented TAG-NGPM+ inactivates SARS-CoV-2 in the specimen, making it safer for transport and handling by laboratory staff.
“PMLS is proud to participate in this collaborative effort with such great institutions as Rutgers and Truckee Applied Genomics,” said Austin Shirley, Director of Operations for Premier Medical Laboratory Services. “Effectively inactivating the SARS-CoV-2 virus and other pathogens before transporting them to labs, while also making the testing more accurate and the handling of the media safer, is a tremendous innovation in specimen collection.”
The TAG-NGPM+ media was developed based on the patented TAG-1™ Class 1 General Reagent. TAG-1 is a formaldehyde-free tissue fixative that was designed to improve molecular tests while requiring no changes to pathology workflows. The TAG-NGPM+ formulation adds sufficient and complementary anti-viral and anti-bacterial components. These components improve the safety of viral sample handling and provide safer and less costly media handling compared to other virus inactivating media since TAG-NGPM+ contains no guanidinium salts.
The studies conducted by PMLS show that the TAG-NGPM+ solution can also be used as an optimal transport media for COVID-19 sample testing. There was a 5 log10 reduction in the viral titer after treatment of SARS-CoV-2 virus with TAG-NGPM+ buffer within 30 minutes while the integrity of the viral RNA remained intact. This might potentially help centralized core laboratories and Point of Care (POC) laboratories safely process patient samples when access to BSL II facilities is limited. Another major advantage the buffer offers is in safe disposal in any disinfectant including 10% bleach solution, since the media is free of hazardous reactive chemicals like guanidinium isothiocyanate (GITC).
Drs. Padmapriya Banada and Sukalyani Banik conducted the studies in the Alland laboratory at Rutgers NJMS. According to Dr. Banada, “the TAG-NGPM+ transport media can potentially reduce the biohazard risk associated with COVID-19 testing, as practice that could otherwise expose laboratory personnel to live SARS-CoV-2, the virus that causes COVID-19. The study showed that the transport media inactivated SARS-CoV-2 at both room temperature and under refrigeration conditions at the tested concentrations. Studies by PMLS also showed that the transport media prolonged sample stability. By improving the safety and stability of COVID-19 test samples, the transport buffer should greatly simplify on-site or point of care testing in settings such as doctor's offices, workplaces or schools”
Dr. Tian Yu, TAG VP of Product Development commented, “TAG-NGPM+ virus inactivation media was designed to increase lab staff safety, while eliminating the need for a cold chain and protecting RNA integrity for weeks at ambient temperature. Because TAG-NGPM+ is designed to better stabilize viral RNA fragments and preserve protein structures, it will enable additional testing formats on top of molecular testing which are known to show high specificity in COVID19 diagnosis.“
The article by Rutgers NJMS and PMLS demonstrating their research findings is soon to be published. For more information, please call 866-405-2199 or visit www.PreMedInc.com.
ABOUT PREMIER MEDICAL LABORATORY
Premier Medical Laboratory Services (PMLS) is a CLIA and COLA regulated laboratory based in Greenville, South Carolina focused on providing clinically meaningful results to medical practitioners. Premier Medical Laboratory Services offers a variety of highly specialized tests including: the only Type II Diabetes molecular predisposition test available in the U.S., advanced cardiovascular testing, hereditary cancer screening, carrier screening, women’s health panels, pharmacogenomics, serum allergy testing, blood wellness, Hepatitis C genotyping, respiratory pathogens, gastrointestinal pathogens, and more. In addition to its specialty programs, Premier Medical Laboratory offers a comprehensive testing menu of general chemistry, immunoassay, and hematology tests. The company also is proud to offer a patient friendly billing policy. For more information, please visit www.PreMedInc.com or call 866-405-2199.
South Carolina featured in JD Supra article see more
South Carolina has long been known for its colorful history, beautiful beaches and vibrant tourist industry. In recent decades, it has also come to be well known for its high-tech manufacturing with the likes of BMW, Boeing, Honda, Michelin, Samsung and Volvo, all locating large manufacturing facilities throughout the State. What you might not know is that South Carolina is also home to another rapidly growing high-tech industry—the Life Sciences industry.
The term Life Sciences is generally used to include companies in the fields of biotechnology, pharmaceuticals, biomedical technologies, life systems technologies, nutraceuticals, cosmeceuticals, food processing, environmental, and biomedical devices. The Life Sciences industry also includes organizations and institutions that devote the majority of their efforts in the various stages of research, development, technology transfer and commercialization, as well as the companies who support these entities.
According to SCBIO, the trade association which represents the Life Sciences industry in South Carolina, there are over 700 companies and businesses actively engaged in the Life Sciences industry in South Carolina and at least one Life Sciences organization is located in 42 of the State’s 46 counties. The economic impact of the Life Sciences industry is approaching $12 billion per year and is continuing to increase, according to a recent study. It is also estimated that the Life Sciences industry has created over 40,000 high paying jobs in South Carolina over the last several years, with an average annual salary of over $70,000.
The Life Sciences industry in South Carolina is very diverse. It includes companies ranging from small startups focusing on developing new technology like Okra Medical, to a unique genetic clinical and research institution like Greenwood Genetic Center, which has been serving the State for decades, to large established companies like Nephron Pharmaceuticals. Nephron is a pharmaceutical manufacturer and cGMP compliant 503(B) Outsourcing facility, and a global leader in the manufacture of generic respiratory medication that has rapidly expanded its manufacturing capacity and services over the last seven years. Nephron is owned and led by Lou Kennedy, whose vision and leadership have spurred the Company’s growth and success and have also made her one of the State’s most important business leaders, as well as an important thought leader in the Life Sciences industry.
South Carolina is a pro-business state that has worked diligently to attract large companies looking for a friendlier business climate from a tax and regulatory perspective. An additional driver for the growth of the Life Sciences industry is the existing ecosystem for Life Sciences, which is supported by the State’s three major research universities: University of South Carolina, Medical University of South Carolina and Clemson University as well as over ten additional universities and colleges in the State - from Furman University with its innovation program and nationally recognized chemistry department, to Newberry College launching new curriculum and a degree focused on pharmaceutical manufacturing. These universities and colleges further validate the increasing depth of the existing ecosystem and the positive impact it will have on strengthening the talent pool available to the Life Sciences industry. Other factors contributing towards this growth are the efforts of the South Carolina Department of Commerce and the South Carolina Research Authority, the strong system of hospitals and health care systems within the State, the support of various economic development alliances, the State’s expanding technical college system, the support of elected officials and the growth and leadership of SCBIO over the last several years.
SCBIO has spearheaded a series of joint private / public initiatives to promote the growth of the Life Sciences industry in South Carolina. These efforts include promoting statewide economic development strategies to attract Life Sciences companies to locate or relocate in South Carolina and consistently promoting and strengthening the existing ecosystem which allows established South Carolina Life Sciences organizations to collaborate, grow and flourish. In addition to its economic development efforts, SCBIO has integrated its efforts with the broader mission to transform and positively impact healthcare as evidenced by its unique alliances forged with the South Carolina Hospital Association, several large health systems and large payers like Blue Cross Blue Shield of South Carolina. For the past four years, SCBIO has been led by its CEO, Sam Konduros. Konduros has experience with economic development, operations of Life Sciences companies, developing start-up companies and most importantly—developing and implementing an ambitious strategic plan for the Life Sciences industry. During his time at SCBIO, Konduros has assembled a talented team. His vision and energy have fueled a rapid growth in membership and engagement and an increased in awareness and support for the Life Sciences industry across the State. Under his leadership, SCBIO significantly expanded its membership and quadrupled its revenues, while at the same time establishing itself as a powerful force for economic development and creating a new platform for Life Sciences companies to collaborate on innovations and research. Earlier this month, Konduros announced his departure from SCBIO to serve on the Board of Vikor Scientific, another successful company within the Life Sciences space in South Carolina that is rapidly expanding. He will also serve as CEO of a new health innovation company powered by artificial intelligence (AI) and blockchain technologies focusing on science personalized medicine strategies that will be a part of Vikor Scientific’s expanding portfolio of companies. SCBIO is conducting a national search for Konduros’ replacement and there is no doubt that the association and its members will continue to benefit from the momentum created over the last four years as it continues to push the Life Sciences industry forward.
The global COVID-19 pandemic presented a profound challenge to the Life Sciences industry as it disrupted the way business was conducted. The Life Sciences industry in South Carolina stepped up to these challenges and turned them into opportunities. Many Life Sciences companies pivoted from their existing strategic plans to address the needs of the State and Nation by providing assistance in key areas that became critical during the pandemic. Companies like Nephron Pharmaceuticals, Vikor Scientific, KIYATEC, Premier Medical Lab Services and others offered much needed expanded COVID-19 testing services inside and outside South Carolina. Others such as ZVerse, a digital manufacturing company, modified its business model to become one of the largest producers of reusable face shields for use during the pandemic and beyond. Over the last 12 months, they have produced millions of these reusable facemasks and have been recognized throughout the country for their efforts. Rhythmlink International, a medical device leader, donated thousands of masks and personal protective equipment (PPE) to hospitals and other healthcare providers across South Carolina. In addition, Milliken & Company boosted its production of biosmart fabrics used in scrubs and lab coats, which uses chlorine bleach-activated technology and molecular engineering to kill up to 99.9% of the bacteria and viruses it touches. Headquartered in Greenville, Vitalink Research was selected by Moderna to run its Phase III vaccine clinical trial, demonstrating national confidence in Life Sciences research operations in South Carolina. These are just a few examples of how South Carolina Life Sciences companies responded to the challenges of the COVID-19 pandemic and highlight why the Life Sciences industry is one of the fastest growing segments of South Carolina’s economy.
The future of the Life Sciences industry is bright in South Carolina. South Carolina has become an attractive place to develop and expand Life Sciences companies and there is great leadership within these companies. The rapid growth of Life Sciences is becoming more apparent to the public and media. In February 2021, Governor McMaster proclaimed February 15-19 as South Carolina Life Sciences Week in the Palmetto State. Our Life Sciences companies are leading the discussions of how to bring more Life Sciences manufacturing back to the U.S, including to South Carolina, and how to develop a domestic source of PPE and other parts of the supply chain. There is also increased collaboration on leveraging increased use of technology like telehealth and digital health to deliver health care services to rural and less developed areas using technology developed and perfected in South Carolina. SCBIO is also leading an effort to expand and improve the workforce to support Life Sciences companies. All signs point to a very bright future for the Life Sciences industry and South Carolina is just beginning to see the benefits of this growth and development.
Trio collaborate to turn back COVID tides see more
It was not long ago when we all witnessed demand for critical Personal Protection Equipment (PPE) far outstripping supply on the front lines of the COVID-19 battle.
While this story line is now receding in our memory, it became a rare instance in South Carolina based on extraordinary efforts from entities like Humimic Medical, South Carolina Biotechnology Organization (SCBIO), and South Carolina Manufacturing Extension Partnership (SCMEP). Not only did these groups address frontline workers, but they also addressed the critical PPE needs of organizations a few layers back from the front lines – such as non-profit community outreach groups, church programs, and workforce development groups.
Humimic Medical teamed up with SCBIO and SCMEP to help these organizations and others out. Leveraging the broad network of SCBIO and connected distribution channels of SCMEP, Humimic Medical donated thousands of face shields to organizations across South Carolina which desperately needed quality, made-in-the-USA protective equipment.
“Helping the ‘little guys’ has always been part of my DNA, I guess,” commented Joel Edwards, CEO of Greenville’s Humimic Medical. “We started in a garage 10 years ago and grew from there. Organizations willing to support the little guy like us along the way helped us tremendously in getting to where we are today. So having the opportunity to give back and help others who may not be first in line to receive PPE supplies just felt right.”
Humimic Medical does not typically produce PPE. However, as they continued to become more deeply entrenched in the collaborative life science ecosystem network that SCBIO has forged in the Palmetto State (which includes groups like SCMEP), they realized they could join the fight against COVID-19. Early in the pandemic, Humimic Medical shifted some of its engineering and manufacturing resources from their medical trainer product lines to help supply PPE where it was needed most.
There was one problem though. Humimic Medical didn’t have the established distribution channels for PPE in South Carolina. That’s where SCBIO’s connection to SCMEP came into play. Organizations like SCMEP also serve as key players in South Carolina’s connected, collaborative, and growth-oriented network. SCMEP’s mission of helping state organizations improve their competitiveness, performance, and profitability provided a perfect backdrop for Humimic Medical to connect to organizations around our state who still desperately needed PPE supplies like face shields.
“SCMEP always prides itself in being a strategic resource for companies in our State”, shared Chuck Spangler, President of SCMEP. “We’re grateful we could leverage our network in collaboration with SCBIO and Humimic Medical to serve organizations in need.”
Added SCBIO Interim CEO Erin Ford, whose team was able to rapidly connect Humimic with key contacts to deliver the new face shields where they are needed most, “We continue to live our mission of being the life sciences industry convener, and that’s more important than ever right now.”
“Organizations SCBIO and SCMEP continue to be invaluable assets in our State,” said Edwards. “The rich, collaborative networks these kind of groups create are what will continue to make South Carolina a leader in new business development.”
About Humimic Medical:
Humimic Medical is a rapidly growing medical trainer and synthetic gel manufacturing company based in Greenville, SC. The company is driven by innovative product design, world-class customer service, and fueled by robust collaborative partnerships with universities and healthcare providers. Humimic Medical utilizes its proprietary synthetic gel blend to more closely represent human tissue elasticity and maintain recyclable/reusable qualities that no other product line currently offers delivered at a significantly lower price point than any existing products.
SCMEP is a private, non-profit group that serves as a proven resource to South Carolina businesses, providing them with a range of innovative strategies and solutions. An affiliate of the National Institute of Standards and Technology (NIST), SCMEP operates under the US Department of Commerce to promote innovation and industrial competitiveness. SCMEP uses a strategic, hands-on, partnering approach to help South Carolina companies improve their competitiveness, performance, and profitability in today’s increasingly demanding global economy.
DPX earns SBIR grant see more
DPX Technologies, a manufacturer of laboratory consumables for sample preparation, receives over $250,000 from the National Science Foundation (NSF) for a Small Business Innovation Research (SBIR) Phase I project. The project involves rapid purification of RNA and the development of fast detection for COVID-19.
RNA extraction is a key pre-analytical sample preparation step for viral RNA detection. Viral RNA detection is the current worldwide strategy used for early detection of the novel coronavirus SARS-Cov-2. The magnitude of the COVID-19 pandemic calls for unprecedented high throughput testing.
DPX Technologies has been developing sample preparation products for high throughput, automated methods for over a decade. Their patented and proprietary pipette tip technology harnesses the power of automated liquid handlers to provide solutions for a variety of applications. DPX was able to leverage the help and expertise of Tyler Tatum at 3Phase SC. “Tyler helped with navigating through all of the paperwork and rules. He was great to work with and extremely knowledgeable,” said William Brewer, CEO of DPX Technologies and principal investigator on the SBIR Award.
The South Carolina Department of Commerce Office of Innovation launched 3Phase in 2018 as a resource aimed at assisting research-based companies in South Carolina successfully acquire Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) awards. 3Phase provides training and workshops throughout the state on the federal SBIR and STTR programs, while managing the application process for a portfolio of companies, both at no cost to participants. The SBIR program funds early-stage research and development and is designed to provide equity-free funding. These investments stimulate technological innovation in the private sector, strengthening the role of small business in meeting federal research and development needs.*
* Excerpt regarding information on 3Phase program from South Carolina Department of Commerce website and https://www.3phasesc.com/
About DPX Technologies
DPX is committed to providing innovative sample purification solutions. We collaborate with our customers to provide the high-quality products they need for complex chemical and biological analysis.
Ahead of Spring Break, Makers of ZShield Product Line Offer Easy Way to Stay Safe, Avoid Coronavirus see more
Digital manufacturing company ZVerse, Inc., makers of the award winning ZShield line of face shield and face mask products, has launched a public service campaign aimed at promoting the best way to stay protected against the COVID-19 virus.
As Spring Break approaches and coronavirus cases remain high across the U.S., ZVerse is recommending a "Good-Better-Best" model for wearing Personal Protective Equipment (PPE) based on public health guidelines and customer feedback.
ZVerse is recommending a “Good-Better-Best” model for wearing Personal Protective Equipment (PPE) based on public health guidelines and customer feedback.
The simple model recommends wearing a face mask as a minimum, or good level of protection, followed by a face mask and a face shield combined for better protection. The best protection comes with wearing a filtered face mask combined with a face shield, according to the ZVerse model.
"Experts are warning of a new pandemic wave if people let down their guard during the upcoming Easter and Spring Break holidays and fail to protect themselves and their loved ones," said ZVerse Founder & CEO John Carrington. "At ZVerse, we have learned so much from our own customers and our own product development journey about how to stay safe. So, we created what we hope is a simple and easy guide for COVID-19 protection."
In addition to raising public awareness, ZVerse is recommending its model to city and state officials looking for an easy way to keep citizens safe.
"ZVerse has been a valuable member of South Carolina's business community for many years, and they really stepped up when they received the call to help combat the COVID-19 pandemic," said Columbia Mayor Steve Benjamin. "Their "Good-Better-Best" model is exactly what we need to not only further the decline of COVID-19 cases, but also build toward a return to normalcy where we work, learn and play in our local communities."
ZVerse designs, manufactures and sells a complete line of acclaimed PPE products popular with consumers, schools, employers and government entities - and often seen covering famous faces across Hollywood
For information about ZShield products and pricing, visit: https://zshield.com/collections/available-products.
ZVerse was founded in 2013 by John Carrington in Columbia SC. ZVerse, a digital manufacturing ecosystem, currently provides the only CAD as a Service (CADaaS) platform and designer marketplace. ZVerse recently launched the next generation of its Digital Manufacturing Enablement (DME) platform, an AI drive workflow solution - a category defining technology for digital manufacturing and OEMs. In 2020, in response to the COVID-19 pandemic, ZVerse adapted its business model to quickly produce and distribute its new personal protective equipment product, ZShield, to hundreds of thousands of citizens. To learn more visit zverse.com and zshield.com.
SCBIO, 3 life sciences companies highlighted in media reports see more
Courtesy Greenville News/Gannett
As the distribution of COVID-19 vaccines have ramped up in recent weeks, life science firms in South Carolina have pivoted to play a role in the vaccination campaign.
After weeks of only 60,000 dose allocations in January, that figure has doubled with over 130,000 first doses expected to arrive in South Carolina this week.
The brands are well known — Pfizer, Moderna, Johnson & Johnson — but lesser known companies have played a role in the clinical trials and ancillary supplies critical to the rollout of the vaccine and some are found in the Palmetto State.
Gov. Henry McMaster celebrated SCBIO, a life sciences non-profit, and the industry in February for their great year. Part of that success was in response to COVID-19.
"While 2020 will forever be remembered as the year of an unmerciful global pandemic, our stakeholders heroically rose to the challenge," Sam Konduros, SCBIO's president and CEO, wrote in the non-profit's 2020 report.
SCBIO and over 100 industry firms supported pandemic efforts such as distribution of personal protective equipment — which includes creating an online PPE exchange portal — creation of a jobs portal, testing and promoted proper mask use on social media.
That list now includes COVID-19 vaccines research and packaging, and potentially its production.
Clinical trials vital to vaccine development
The Moderna vaccine was authorized for emergency use on Dec. 18 after clinical trials proved its effectiveness and safety. VitaLink, a Greenville based research company, played an important role in Moderna's phase 3 trials.
South Carolina had four Moderna phase 3 clinical trial locations out of the nearly 100 locations around the country. Three trial locations — Anderson, Greenville and Spartanburg — were conducted by VitaLink Research, a South Carolina based research company which specializes in respiratory medicine.
"It really was just a natural fit for us," Steve Clemons, VitaLink's CEO and president, said.
Clemons expected roughly 400 participants through the three sites but the Upstate had roughly 1,200 of the 30,000 enrolled participants nationwide.
"There should be an awful lot of pride to the Upstate because, frankly, we as VitaLink couldn't have done this without the volunteers," Clemons said.
Participants were enrolled in the summer and either received the drug or a placebo.
One of these participants was George Acker who has learned since talking with The News in November that he got the placebo — to his surprise.
The studies were unblinded in January and those who received the placebo were able to get the real vaccine.
Acker has received both shots since then.
VitaLink continues to conduct monthly follow-ups with participants for two years to track side effects, safety and efficacy of the vaccine.
Nearly 400,000 doses of the Moderna COVID-19 vaccine have been administered in South Carolina in the last three months.
The Moderna product has played a vital role in vaccinating long-term care facility residents and staff as initial allocations were given to these populations.
Clemons is proud that VitaLink has played a part in the solution to the pandemic but also in their work in general.
"I get to treat people every day using, kind of, tomorrow's therapies," Clemons said. "And I get paid to do it and patients never get billed."
Packaging of Pfizer vaccines
The Pfizer-BioNTech vaccine requires ultra cold storage, around minus 70 degrees Celsius. This makes shipment a little more challenging but a local packaging company had the solution.
They supply ultra-cold temperature shippers which keep vaccines between minus 90 and minus 60 degrees Celsius for at least ten days unopened with the use of dry ice and insulation. If managed well, these reusable containers can store vaccines for about a month by re-icing the dry ice.
"[Softbox] immediately understood the unprecedented task at hand that was in front of us with the distribution of the vaccine," Tanya Alcorn, Pfizer's vice president for biopharma global supply chain, said in a March 10 press release. "And quickly started to work with us to develop a unique packaging system that does not waste any precious vaccine and creates a seamless experience for customers.”
One of two manufacturing centers supporting the vaccine distribution is located in Greenville, the other is in the Netherlands.
"Our Americas headquarters in Greenville features a full qualification testing lab, product engineering capabilities, and a world-class team," John Hammes, Softbox's general manager of the Americas, said. "All of which helped us support Pfizer in the fight against COVID and develop a way to successfully distribute a vaccine to support the global community."
Vaccines could soon be filled in the Lowcountry
Lou Kennedy didn't expect on her company would be filling vaccines, but she also didn't plan on the pandemic — no one did.
In addition to helping with COVID-19 testing efforts, she thought Nephron Pharmaceuticals could take it a step further and help with the vaccinations.
"We have the type of equipment already in our possession, we will have it retooled," Kennedy said. "We'll build a wing and it is our sincere desire to find a vaccine partner — like Moderna, Pfizer or Johnson & Johnson — and say, let us fill some of the capacity that the American patient needs."
The Lexington County-based company is currently undergoing a $215 million expansions which includes a 110,000 square foot vaccine production space. Kennedy expects at least 380 new jobs with the expansion.
About 300 of those could be centered around the vaccine production and she hopes to partner with a COVID-19 vaccine manufacturer to fill vaccines and help ramp up vaccine supply.
Nephron is currently working to find a vaccine partner. It could be Moderna, Pfizer, Johnson & Johnson, or it could be another brand who could receive authorization in the U.S., Kennedy said.
"Between now and the time we move in there, there could be 10 new ones, so we're keeping our eyes and ears open," Kennedy said.
They've already hired about half the people they need. The building is still being worked on but once it's completed, Kennedy believes the production lines could be operational by the summer.
The expansion, originally announced in July, will also include a new office, a new warehouse, expanded secondary packaging operations and a 20,000 square foot machine shop.
In the meantime, Nephron Pharmaceuticals already partnered with Dominion Energy to set up a drive-thru vaccination site in Lexington County in February.
"I had this idea that why can't we help the vaccination," Kennedy said. "We have nurses on staff and we have [doctors of pharmacy]."
Dominion Energy provided the space and set up a temporary power pole for Nephron's nurses and staff. They also enlisted the help of Rick Lee, a Department of Environmental Control board member from Rock Hill, on how to best setup a drive-thru clinic.
Like health systems across the state, Nephron is running this clinic out of their own pocket. Vaccines and ancillary supplies are supplied by the government, but staff and other costs are not.
"We're not getting reimbursed for any of this," Kennedy said. "We're doing this out of the bottom of our heart."
The drive-thru site has ramped up from about 30 vaccinations per day when it first opened to about 150 vaccinations per day by March. Kennedy hopes to get this up to 300 per day.
Diversified Medical Healthcare Celebrates One Year Since FGDA Validation of State's First COVID-19 Testing LabCompany has processed over one million COVID tests see more
Diversified Medical Healthcare (DMH), a holding company with four subsidiary healthcare companies, Premier Medical Laboratory Services (PMLS), CPT Medical, OnGen, and Vessel Medical, has provided leading-edge solutions to combat COVID-19 nationally, addressing supply chain gaps and infrastructure restrictions caused by the virus. Their molecular diagnostics laboratory, PMLS, became the first lab in South Carolina validated as an independent COVID-19 testing lab one year ago. Just as PMLS achieved this validation for testing shortly after the first case was reported in the US, they continue to meet demands caused by COVID-19 as they arise with their laboratory staff of over 360 employees and in-house research and development team of Ph.D. scientists. Along with large scale testing via state of the art automated lab equipment, DMH companies developed advanced software for most efficient data management, distributed customized PPE supply kits, and manufactured COVID-19 testing kits as well as viral transport medium that properly preserves specimens during transit.
“Since COVID-19 became a threat to our nation, we quickly streamlined our workflow, hired employees, validated various coronavirus assays, and purchased the equipment needed to test a large volume of specimens with the highest quality standards,” said Kevin Murdock founder of Diversified Medical Healthcare. “With our laboratory having one of the highest testing capacities in the nation, an in-house medical manufacturing firm, a lab equipment company, and data management software company, we feel that it’s imperative to do our part to help keep the country open and our citizens safe.”
At this one year mark, PMLS has processed over one million (1,000,000) tests to determine COVID-19 results for patients nationwide. With their highly advanced laboratory information management system (LIMS) created by OnGen, data is communicated directly from high throughput laboratory equipment for fast, accurate storage and delivery of data to healthcare providers and patients. Many of PMLS’ lab processes are automated to allow them a testing capacity of 300,000 tests per day. With this scalability, PMLS has enabled other laboratories and testing sites to increase their testing capacity and turnaround of results with Virtual Lab. An innovative COVID-19 testing solution to overcome laboratory infrastructure restrictions, Virtual Lab allows these facilities to utilize PMLS’ fully-automated robotic workflow and team of 360 employees to largely increase their testing capacity and efficiency while bypassing the need to purchase new equipment or endure waiting time of weeks or more for shipping, installation, and validation. Along with helping other labs, hospital systems and large organizations to test more patients, Diversified Medical Healthcare has donated hundreds of thousands of masks to local law enforcement, paramedics, fire departments, hospitals, and the Shriners organization and has provided free testing to first responders during the pandemic.
As another means to aid laboratories, healthcare systems, and large organizations in the expansion of their COVID-19 testing, Vessel Medical offers Lab in a Box, turnkey lab equipment that comes with everything needed for professional laboratory level diagnostics for COVID-19, Flu A and B, upper respiratory, STD/UTI, cancer risk screening, pharmacogenomics, and antibiotic resistance testing. Developed by leading scientists and technicians in partnership with Hamilton Company, Thermo Fisher, and Grenova, Lab in a Box enables a high capacity of onsite diagnostics for hospitals, expanding laboratories, schools, and large companies in need of quick and accurate testing results. With precision robotic instruments, lab in a box includes high throughput liquid handling along with automated, custom-programmable pipetting that decreases human error and result turnaround time.
Another DMH company, CPT Medical, shifted their production of surgical supplies to include manufacturing of COVID-19 testing kits since the beginning of the pandemic. CPT Medical is now capable of manufacturing 60,000 test kits per day and works in conjunction with PMLS to offer customizable testing to large organizations. Some of the large organizations that PMLS has partnered with as the official COVID-19 testing lab are the United Soccer League (USL) and Division I/Division II teams in 7 collegiate conferences as well as large schools and business organizations across the US. PMLS is also the processing lab for Human Health Services surge sites and state health departments in South Carolina, Arizona, Utah, and North Carolina and is the Blue Cross Blue Shield preferred COVID-19 testing lab in Texas, South Carolina, and North Carolina. Through all of these partnerships, PMLS has continued in their reputation of delivering the most advanced testing with rapid, reliable results, and diligent customer care.
Now, as vaccines are administered and restrictions on social distancing are being lifted, PMLS is conducting a critical large scale genomic sequencing for the surveillance of new COVID-19 variants, taking proactive measures so that a future surge of a mutated Sars CoV-2 strain is less likely to occur. The data collected from genomic sequencing can help pharmaceutical companies to stay ahead of the variants and make any changes needed to the current vaccines and treatments for higher efficacy and best patient outcomes. With PMLS’ high throughput genomic sequencers and library prep instruments that automate the library prep and sequencing process, a much higher capacity for genomic sequencing is achieved and margins of human error are drastically reduced. By sequencing an exponentially higher amount of specimens, PMLS is better equipped to provide meaningful analysis with larger amounts of data and faster turnaround times for the effective surveillance of SARS-CoV-2. PMLS is in discussions with the CDC and multiple states across the nation to provide COVID sequencing services at ports of entry and local and regional hotspots. Along with this and their previous accomplishments, more groundbreaking COVID-19 solutions by Diversified Medical Healthcare are soon to be announced.
For more information, please visit www.divmedinc.com or call 866-521-7541.
Softbox a key player in battle to beat COVID see more
Softbox, a leading global innovator and provider of passive temperature control packaging solutions for the pharmaceutical, life science and cold chain logistics industries, is proud to support Pfizer in the distribution of Covid-19 vaccines through the supply of a high-performance temperature-controlled parcel shipper developed specifically for ultra-low temperature applications.
Softbox supported Pfizer with the development of the highly specialised and reusable ultra-low temperature (ULT) shipper to help them on the distribution of ultra-low temperature vaccines and storing them at Point of Use (POU) sites.
Ultra-Low Temperature vaccines, such as that developed by Pfizer – BioNTech, uses mRNA (messenger RNA) technology and must be stored at temperatures between -90°C to -60°C to ensure that the vaccine’s quality and efficacy is maintained. The ULT shipper is capable of maintaining the required temperature during shipping of Covid-19 vaccines between -90°C to -60°C for at least 10 days unopened.
The highly innovative shipper utilises high performance insulation materials, incorporated in a robust and reusable construction, in conjunction with dry ice, to ensure long term ultra-low temperature control. Based on current guidelines, the Softbox ULT Shipper can be opened twice a day, for up to three minutes at a time. This allows clinicians at Point of Use (POU) sites to access the vaccine vials required for each day’s immunisation clinics without exposing the remaining vaccine stored within the shipper to ambient temperatures, thus ensuring integrity of the vaccine is maintained.
When correctly managed, the ULT Shipper can be used to store vaccines for in excess of 30 days. Through a process called “Re-Icing” the dry ice in the Softbox ULT Shipper can be topped up ensuring maximum thermal protection of the highly temperature sensitive mRNA vaccines.
“Softbox’s extensive knowledge and experience in temperature control packaging solutions and the cold chain industry was the right choice for us. They immediately understood the unprecedented task at hand that was in front of us with the distribution of the vaccine, and quickly started to work with us to develop a unique packaging system that does not waste any precious vaccine and creates a seamless experience for customers.” said Tanya Alcorn, Vice President, Biopharma Global Supply Chain for Pfizer. “Their technical capabilities and innovative approach helped us achieve an excellent result in a very short period of time.”
Kevin Valentine, CEO of Softbox, said: “We are immensely proud to be playing such an important role in the fight against Covid-19. We worked extremely hard during 2020 to help Pfizer develop this highly innovative ULT shipper; establishing one of the world’s largest fleets of reusable temperature-controlled parcel shippers in the process and setting up two world-class service centres to support ULT shipper refurbishment.”
“It’s a huge honour to have the opportunity to support the distribution of these vital vaccines at the right temperature, maintain their integrity and help save millions of lives.”
For more information about Softbox visit: www.softboxsystems.com
Softbox is an award-winning temperature control packaging innovator that has been designing and producing high performance passive temperature control packaging solutions for over 20 years. We offer consistent quality to our clients from our strategically located global manufacturing sites throughout Europe, North America, Latin America, India and Asia Pacific.
We have formed long standing partnerships with the world’s leading pharmaceutical, clinical research, biotech and logistics companies, and apply innovative thinking to overcome the challenges that our clients face in managing the Cold Chain when shipping temperature sensitive clinical trial and commercialised products.
For more information about Softbox visit: www.softboxsystems.com
Johnson & Johnson COVID-19 Vaccine Authorized by FDA; First Single-Shot Vaccine in Fight Against Global PandemicShipping vaccine immediately, delivering more than 20 million doses to U.S. in March see more
Johnson & Johnson (NYSE: JNJ) (the Company) has announced that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for its single-dose COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, to prevent COVID-19 in individuals 18 years of age and older.
This decision was based on the totality of scientific evidence, including data from the Phase 3 ENSEMBLE study that demonstrated the vaccine was 85 percent effective in preventing severe disease across all regions studied, and showed protection against COVID-19 related hospitalization and death, beginning 28 days after vaccination.
The terms of the EUA allow use of the vaccine while more data are gathered. The Company plans to file for a Biologics License Application (BLA) with the FDA later in 2021.
“This milestone follows a year of incredible work by our dedicated teams and unprecedented collaboration with health leaders around the world – all of whom shared a goal of bringing a single-shot vaccine to the public,” said Alex Gorsky, Chairman and Chief Executive Officer at Johnson & Johnson. “We will do everything we can to help bring this pandemic to an end, in the United States and throughout the world.”
$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.
"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
Governor McMaster Issues Proclamation Recognizing South Carolina Life Sciences Week to Celebrate State’s Fastest-Growing IndustryGovernor 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.
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/.
Nephron, Lexington County businesses step up again see more
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.
Single shot may be enough for AZ vaccine see more
Britain’s health chief says a new study showing that a single dose of the COVID-19 vaccine developed by Oxford University and AstraZeneca provides a high level of protection for 12 weeks supports the government’s strategy of delaying the second shot so more doses can be delivered to more people.
Health Secretary Matt Hancock’s comments came after Oxford released a study showing the vaccine cut transmission of the virus by two-thirds and prevented severe disease. The study has not been peer-reviewed yet, but it was greeted with excitement by U.K. officials under pressure to justify their decision to delay the second dose.
“That reduction in transmission, as well as the fact there is no hospitalizations, the combination of that is very good news. And it categorically supports the strategy we’ve been taking on having a 12-week gap between the doses,” Hancock told Sky News on Wednesday.
One of the lead researchers on the project, Dr. Andrew Pollard of Oxford University, said Oxford scientists believe the vaccine will continue to offer protection against new variants of COVID-19, although they are still waiting for data on this.
Even if the virus adapts, “that doesn’t mean that we won’t still have protection against severe disease.’’
“If we do need to update the vaccines, then it is actually a relatively straightforward process it only takes a matter of months, rather than the huge efforts that everyone went through last year to get the very large-scale trials run,” he told the BBC.