Vigilent Labs to distribute COVID-19 test kits and digital health credentials see more
Enables Vigilent Labs to distribute COVID-19 test kits and digital health credentials to government organizations through GSA schedule
Vigilent Labs, an advanced health and medical technology company that provides solutions for the detection, identification and assessment of health and bio-threats, has formed a partnership with Seroclinix and Davenport Aviation to distribute COVID-19 test kits and Vigilent Labs v.Pass digital credential technology through Davenport Aviation’s General Services Administration (GSA) Contract.
“Our government division has worked on adding much-needed medical supplies to our GSA contract to meet our nation’s most pressing needs during the COVID-19 pandemic,” said Rob McMillin, Davenport’s Senior Program Manager. “We are pleased to partner with Vigilent Labs and Seroclinix to provide test kits to government customers through our GSA Contract (#GS-07F-139DA).”
The COVID-19 Rapid Test kit partnership with SeroClinix’s cost-effective SIENNA Antibody Tests produces fast, reliable and accurate results in seven to 10 minutes, which are CE-marked useful for COVID-19 screening and surveillance under CDC guidance, recently received high marks fro3m the latest International Journal of Infectious Diseases evaluation, and now authorized and approved for purchase through GSA Advantage. A critical advantage of this partnership is the Vigilent Labs “v.LABS” platform and its ability to convert the SIENNA test results into a digital credential that includes one’s COVID-19 Test Results in a v.PASS, facilitating near-real-time health surveillance.
“Vigilent Labs leverages our existing capability with leading-edge technology to provide a comprehensive solution to the medical community from the Point Of Care environment to the executives and managers responsible for healthcare decision making,” said John Falk, President of Vigilent Labs. “We are proud of this strategic partnership and to provide quality testing and credential solutions to government organizations.”
This partnership marks an important milestone for Vigilent Labs as an authorized GSA/Government reseller and distributor for COVID-19 Antigen and Antibody test kits in the United States for the United States government.
“We are excited for our partnership with Vigilent Labs in providing fast and effective test kits for the government,” said Howard Lee, Chief Executive Officer of Seroclinix. “These tests are not only cost-effective but also have the highest reviews made by independent medical evaluations as to the accuracy of the test.”
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 www.vigilentlabs.com.
Senator views progress one year later see more
Senator Tim Scott’s senior staff visited Diversified Medical Healthcare (DMH) headquarters, touring the Greenville, SC facility which houses four healthcare companies making a national impact. Premier Medical Laboratory Services (PMLS), CPT Medical, OnGen, and Vessel Medical serve as a large-scale molecular diagnostics lab, clinical test kit manufacturer, surgical kit manufacturer, medical data management software firm, laboratory equipment supplier, and PPE kit supplier.
Just one year ago, Diversified Medical Healthcare’s laboratory, PMLS, became the first lab validated for COVID-19 testing in South Carolina alongside their other advanced clinical diagnostics offerings. Providing an inside look at their 40,000 sqft faciltiy for the US Senator’s staff, DMH founder, Kevin Murdock introduced them to the company’s research and development team of Ph.D. scientists and over 450 employees as well as showcased the cutting edge laboratory automation equipment which has allowed them one of the highest laboratory testing capacities in the nation.
“From leading research and innovation to generously donating PPE for our front line workers, Diversified Medical Healthcare has been a valuable partner for South Carolina as we’ve worked to get through the pandemic,” said Senator Scott. “Their efforts highlight the life-saving impact of American innovation, and I am proud of the work they have done.”
The senator’s staff toured the laboratory where over 1,000,000 COVID-19 tests were processed during the last year and data has been managed by their laboratory information management software developed in-house. They viewed CPT Medical where over 6,000,000 COVID-19 testing kits and viral transport media have been manufactured and saw the Vessel Medical facility where hundreds of thousands of customized PPE supply kits were assembled and distributed.
In the laboratory, PhD Scientist, Vidhya Narayanan spoke with them about a large scale genomic sequencing that Premier Medical Laboratory Services is conducting for the surveillance of new variants of the Sars CoV-2 virus. As the only laboratory in the US fully automated for Next Generation Sequencing, PMLS expects to sequence up to 84,000 specimens per week. This will be a critical contribution in preventing a future surge of new COVID-19 variants.
“It was a high honor to have Senator Tim Scott’s team here and to show them all that we’re doing right here in South Carolina to improve healthcare across the US,” said Kevin Murdock, founder of Diversified Medical Healthcare. “Senator Tim Scott has done much to improve healthcare and create jobs, and those are two of the driving forces behind what we do here as well.”
The visit of Senator Tim Scott’s staff, comes just two weeks after SC State Representatives, Bobby Cox and Bruce Bannister visited the facility to view all that DMH is doing to contribute to healthcare in the state of South Carolina and the nation.
Over the past year, Diversified Medical Healthcare companies have also:
- Reached one of the highest testing capacities in the nation with the capability to process over 300,000 tests per day
- Developed medical data management software that communicates directly from laboratory equipment for faster delivery of data to healthcare providers and patients
- Developed Virtual Lab, an innovative solution to laboratory infrastructure limitations which allows other labs to utilize PMLS’ testing capacity, 450 employees including a research and development team of PhD scientists, and top of the line lab equipment
- Developed Lab in a Box, turnkey lab equipment for other labs, hospital systems, and large organizations 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
- Shifted production to add in-house manufacturing of COVID-19 testing kits
- Achieved the capacity to produce 60,000 COVID-19 testing kits per day
- Become the official COVID-19 testing lab for 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
- Become the processing lab for Human Health Services surge sites and state health departments in South Carolina, Arizona, Utah, and North Carolina
- Become the Blue Cross Blue Shield preferred COVID-19 testing lab in Texas, South Carolina, and North Carolina
- 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
For more information, please visit www.divmedinc.com or call 866-521-7541.
ABOUT DIVERSIFIED MEDICAL HEALTHCARE
Diversified Medical Healthcare (DMH), a holding company with four subsidiary healthcare companies, Premier Medical Laboratory Services (PMLS), CPT Medical, OnGen, and Vessel Medical. PMLS is an advanced molecular diagnostics lab fully certified by top laboratory accrediting organizations, including Clinical Laboratory Improvement Amendments (CLIA) and COLA. PMLS testing menu includes Pharmacogenomics, COVID-19 testing, Advanced Cardiovascular Testing, Diabetes, Women’s Wellness panels, Allergen Specific Ige Blood Testing, Toxicology, and a first of its kind predictive genetic test for type II diabetes, DiabetestPredict. CPT Medical, Inc. has manufactured surgical custom and standard procedure trays, packs, and kits assembled to fit specific needs and requirements for over 15 years. Now, CPT Medical also manufactures and distributes COVID-19 testing kits with the FDA recommended viral transport medium as well as nuclease free water for laboratories. OnGen is an advanced Laboratory Information System that automates laboratory processes for higher efficiency, accuracy, and profitability. Vessel Medical, since its inception in 1991, has been committed to providing physician’s offices, hospitals, laboratories and their employees with the right workflow solutions, medical supplies, and medical equipment for their needs. Included in their medical equipment offerings is ‘Lab in a Box,’ turnkey laboratory equipment that can turn a 600 sq. ft. room into a COVID-19 testing facility with the capacity to process up to 12,000 tests per day within 24 hours. For more information, please visit www.divmedinc.com or call 866-521-7541.
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.
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.
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.
Softbox Systems the partner of choice for Pfizer vaccine see more
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.
EUA means help is on the way to millions worldwide as the first vaccine for COVID-19 is rolled out see more
The Food and Drug Administration on Friday granted emergency authorization to Pfizer and BioNTech's coronavirus vaccine, clearing its use after a historic 10-month research sprint and a rapid review that culminated Thursday with the endorsement of an independent advisory committee.
With the vaccine's authorization, millions of vulnerable U.S. residents could soon have a shot at protection from a resurgent COVID-19 pandemic that has claimed hundreds of thousands of lives and sickened millions. Daily case counts and deaths have hit new highs in the weeks following Thanksgiving and more than 100,000 people are currently hospitalized.
Initial supplies, however, are extremely limited, forcing public health officials to prioritize which groups should receive the vaccine first. Healthcare workers and nursing home residents, who have fallen ill and died from COVID-19 in disproportionate numbers, are expected to begin receiving the vaccine within days, as Pfizer began manufacturing while clinical trials were still underway.
Some 2.9 million doses are expected to be available initially, with the U.S. holding some in reserve to ensure people receive the second of two doses that vaccination requires.
"While not an FDA approval, today's emergency use authorization of the Pfizer-BioNTech COVID-19 vaccine holds the promise to alter the course of this pandemic in the United States," said Peter Marks, director of the FDA division that reviews vaccines, in a statement.
Authorization of a vaccine within a year of scientists identifying the new coronavirus is a scientific milestone that, at the pandemic's outset, looked unattainable.
"In my wildest dreams, I thought it would be fast. But fast means, if it [typically] takes seven years, maybe you can get it down to a couple of years," said Anthony Fauci, in a Dec. 11 interview with the editor of JAMA. "Now it's our challenge to convince people that this wasn't rushed in a reckless way."
Yet the FDA has been under immense pressure to speed an approval and, on Friday, the Trump administration reportedly told agency head Stephen Hahn to submit his resignation if Pfizer and BioNTech's vaccine was not cleared by the end of the day. The vaccine was cleared by regulators in the U.K., Bahrain, Canada, Saudi Arabia and Mexico earlier this month.
The emergency use authorization, a special type of approval used in public health crises, came one day after a panel of FDA advisers voted 17-4 to recommend use of the shot.
Two of the four "no" votes came from committee members who wanted to recommend the vaccine only for people aged 18 or older, rather than include 16- and 17-year olds as the FDA had advocated. The FDA's final decision authorized its use for people as young as 16.
The regulator, along with its advisers, was persuaded by a massive trial that enrolled 44,000 people and randomly assigned them to receive either Pfizer and BioNTech's vaccine or a placebo.
Trial results announced Nov. 18 showed the vaccine to be 95% effective in preventing COVID-19, easily surpassing the 50% threshold set by the FDA earlier this year. Vaccination was similarly protective in older adults and in individuals of different races or ethnicities, according to detailed data presented at Thursday's meeting.
"The data are pretty clear cut so it's a very straightforward decision," said Philip Grant, an infectious disease doctor at Stanford University Medical Center.
Importantly, Pfizer and BioNTech also proved their vaccine is safe, with no unexpected or serious adverse reactions observed in the study. Many participants did experience injection site pain, fever, headache and fatigue, generally mild or moderate in nature.
While the companies first reported positive results from their Phase 3 study on Nov. 9, they waited 11 more days before submitting an application in order to collect at least two months' of safety follow-up on half of trial participants. Most side effects to vaccines emerge within 40 to 60 days, which motivated the FDA to set the two-month requirement.
Four cases of Bell's palsy — temporary weakness or paralysis in one side of the face — were reported among trial volunteers who received the vaccine, three of which had resolved. FDA reviewers, however, noted the frequency was no greater than what would be expected in the general population.
Regulators in the U.S. and elsewhere are also on now watch for signs of allergic reactions to vaccination among individuals with a history of severe allergies, after two people in the U.K. had reactions after receiving their first shot. The authorization from the FDA instructs medical personnel not to give the vaccine to people who have a history of severe allergic reaction to any of its ingredients.
The emergency clearance for Pfizer and BioNTech's shot is expected to be followed quickly by one for a similar type of vaccine developed by Moderna. An advisory committee is scheduled to meet and vote on the company's application on Dec. 17.
Study results showed Moderna's vaccine, which was developed in collaboration with U.S. government scientists, to be similarly effective against COVID-19.
The shots' high efficacy could help convince skeptical portions of the public who have indicated in polls they'd be cautious or unlikely to get a vaccine.
"There will be less vaccine hesitancy in March than there will be in January, and then a lot less in May than in March," said Larry Corey, a virologist at the Fred Hutchinson Cancer Research Center and co-leader of a vaccine trial network.
It's still unclear, however, whether either vaccine can protect against infection and transmission, as well as disease. Data from Pfizer could come soon, however, Kathrin Jansen, the company's head of vaccine research and development, told the FDA's advisers Thursday.
Both companies have worked feverishly to scale up manufacturing in preparation for an approval, but both will only have limited supplies to offer the U.S. and other countries in which their vaccines are approved.
Pfizer and BioNTech, which make their vaccine at sites in Michigan and in Puurs, Belgium, expect to make 50 million doses by the end of 2020, only some of which is reserved for use in the U.S. Production should ramp up considerably in 2021, when the two companies expect to manufacture up to 1.3 billion doses.
Moderna has said it can produce 20 million doses for the U.S. this month, and another 85 million to 100 million by the end of March.
The U.S. initially preordered 100 million doses of each vaccine, an amount that would cover less than a third of the U.S. population. According to The New York Times, the U.S. passed up its chance to order more doses from Pfizer under an option it had negotiated, although officials dispute the Times' account.
On Friday, Moderna announced the U.S. had agreed to purchase another 100 million doses for delivery in the second quarter of 2021. The U.S. also appears to be counting on approvals for several vaccines still in testing by AstraZeneca, Johnson & Johnson and Novavax. Deals with the three companies reserve some 500 million doses for the U.S.
Moncef Slaoui, the scientific leader of the U.S.'s "Operation Warp Speed" vaccine program, recently predicted 100 million U.S. residents will get a vaccine by the end of February — an ambitious target even if two shots are approved.
Further complicating roll-out plans are the temperature requirements for Pfizer and BioNTech's vaccine, which must be shipped and stored at minus 70 degrees Celsius. Pfizer built shipping containers that will use dry ice to keep doses cold, and is handling distribution on its own.
Dry ice has been in short supply this year, requiring logistics companies to beef up production to meet the demand of transporting vaccines.
Moderna's vaccine must also be kept cold, but at a more moderate minus 20 degrees Celsius.
South Carolina life sciences company adding 148 new jobs to booming industry see more
Vikor Scientific, LLC, a molecular diagnostics company, today announced plans to expand operations in Charleston County. The $1 million investment will create 148 new jobs.
Founded in 2018, Vikor Scientific, LLC specializes in antibiotic stewardship and tangible solutions for the practice of value-based medicine in the treatment of infectious disease. The company provides clinicians with advanced molecular methodology for pathogen detection, quantification and resistance gene identification.
Located at 22 Westedge Street in Charleston, Vikor Scientific, LLC's expansion will increase the company's capacity to assemble and distribute both COVID-19 and full molecular panel testing kits across the country.
The expansion is expected to be completed by January 2021. Individuals interested in joining the Vikor Scientific, LLC team should visit the company's careers webpage.
"The prior backorder of testing supplies was crippling for the U.S. during the beginning of the pandemic, and no one wants to experience that again. This expansion will help us to continue to stay ahead and increase the production of our testing kits for both COVID and our other infectious disease molecular panels by the hundreds of thousands, which is vital as we enter the sick season." -Vikor Scientific Co-Founder Shea Harrelson
"Vikor Scientific, LLC's expansion and the 148 new jobs it will create will have a huge impact in Charleston County and across the state. We couldn't be more excited to continue this partnership and watch them succeed here for years to come." -Gov. Henry McMaster
"Team South Carolina works hard to offer businesses a strong foundation to foster growth and be successful. Vikor Scientific, LLC's decision to expand in Charleston County is an indication that we are doing it right, and we look forward to supporting this great company every step of the way." -Secretary of Commerce Bobby Hitt
"Charleston County offers an environment supportive of innovation, which is a catalyst for our growth in the life sciences industry. We welcome Vikor Scientific's expansion, as it will have a positive impact on our economy with the creation of 148 new jobs." -Charleston County Council Chairman Elliott Summey
"As we continue to respond to the effects of the coronavirus pandemic, the remarkable work of companies like Vikor Scientific has proven critical to keeping our citizens healthy and safe. Not only will this expansion create 148 new jobs in Charleston, but it will increase our ability to provide COVID-19 tests to those who need them throughout the state and across the country. On behalf of the citizens of Charleston, I'd like to thank Vikor Scientific for the lifesaving work they do in our community and wish them Godspeed as they continue to expand operations." -Charleston Mayor John J. Tecklenburg
"Vikor Scientific is a young company making a monumental impact within the life sciences industry, and we are grateful this important work is happening in our backyard. Congratulations to Vikor Scientific on this significant expansion and we look forward to our continued partnership." -Charleston County Economic Development Executive Director Steve Dykes
FIVE FAST FACTS
- Vikor Scientific, LLC is expanding operations in Charleston County.
- The $1 million investment will create 148 new jobs.
- Vikor Scientific, LLC is a molecular diagnostics company.
- Located at 22 Westedge Street in Charleston, S.C.
- Individuals interested in joining the Vikor Scientific, LLC team should visit the company's careers webpage.
SC company to play role in vaccine distribution see more
A South Carolina pharmaceutical company will play a huge role in getting a COVID-19 vaccine to the American people.
Columbia-based Ritedose Corporation announced Thursday it’s been named a partner in Operation Warp Speed and will be responsible for filling and packaging millions of vaccines.
ApiJect, a medical technology company that received $138 million from the federal government to produce the first 100 million COVID-19 vaccines, patented the vial in which the vaccine will be distributed. They needed Ritedose to produce and manufacture those vials with their blow-fill-seal technology.
Ritedose CEO Jody Chastain says more COVID-19 vaccines will be packaged and filled in Columbia than any other place in the country.
“It’s tremendously rewarding,” Chastain explained.
He and his employees did the near impossible, getting two 150,000 square-foot warehouses ready to package and fill the vaccines in only a few months.
“Typically, that would take anywhere from 18-24 months, but within five months, we were able to outfit the facility to be able to handle the vaccine,” said Chastain.
Ritedose has upped its staff by more than 10% to help handle the demand.
“The potential for the workforce here in Columbia is huge, as well as putting Columbia on the map in the response to COVID,” Chastain noted.
The company’s nearly 400 employees also learned Thursday the role they will play in distributing the vaccine.
“It’s been hush-hush around the facility,” said Chastain. “People know that we’ve been doing work around the facility to be able to handle a new product, but they were unaware of what the new product is. Making this announcement to the employees today was very exciting because they’ve been able to see a tremendous amount of pride that’s been able to go into the workforce to be able to handle the vaccine.”
As soon as a vaccine candidate receives FDA approval, Ritedose will work with the company to make sure the vaccine is compatible with their plastic packaging.
“We’re much more efficient,” said Chastain. “We can produce a higher volume in a shorter time period.”
Once the vaccine is rolled out, front line workers, like Prisma Health Baptist Parkridge doctor Jennifer Risinger, will be the first in line.
“I’m very encouraged that we’re looking at months instead of years,” said Risinger.
She says she and her colleagues are eager to get the vaccine.
“It does give us a sense of relief and confidence that we’ll be able to deliver the care that people here in the Midlands deserve,” she noted. “I think we should all be very proud that we have a local company who is this involved in bringing this to the national spotlight as soon as possible.”
Ritedose says it’s likely the first vaccines distributed in South Carolina will have been packaged and filled in Columbia.
Operation Warp Speed has a goal to produce and deliver 300 million safe and effective doses of the COVID-19 vaccines, with the first doses expected to be ready by January 2021.