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.
Vigilent Labs to call Charleston, South Carolina home see more
Compliments of Charleston Post and Courier
Congratulations to our colleagues in Charleston County for this excellent announcement, advancing the growth of life sciences in South Carolina. Read the full story here.
A technology firm with ties to the U.S. defense industry said Thursday it will invest nearly $105 million in a facility on the former Navy base in North Charleston that the company says will manufacture COVID-19 test kits.
Vigilent Labs said it will hire 400 workers to produce FDA-approved test kits that can detect COVID-19 antibodies and antigens in 10 minutes or less.
Manufacturing will begin in December and the company said it also will move its headquarters to the site at 1105 Truxton Ave. Vigilent is currently based in Alexandria, Va., near the nation’s capital, and it was incorporated in Wyoming. Read on for full details.
Charleston, Vikor Scientific featured in national media see more
Empty hotel rooms, half-full offices, and shuttered retail. The coronavirus has wreaked havoc on the most established commercial real estate asset classes, creating short-term financial crunches and raising long-term secular concerns as remote work is tested and e-commerce rates rise.
Other asset classes, once alternatives, have become institutional investing gold standard. Logistics assets such as warehouses are providing a punch to the portfolio of the world’s largest landlord, Blackstone.
As industrial real estate investing becomes more crowded, and many of the other large asset classes slump, attention is turning to life sciences real estate — or space that’s used by pharmaceutical and biotech companies for research, development, and even manufacturing of new diagnostics, therapies, and vaccines.
The life science industry had been growing rapidly before the pandemic, attracting $17.4 billion in venture capital funding in 2019, up 370% from $3.7 billion in 2008, according to a Cushman & Wakefield report. Funding has continued to pour into the sector, even as coronavirus has slowed down venture funding overall, creating demand for more lab space.
Belimed Steam Sterilizers now announced compatible for crisis strategy decontamination of specific single-use N95 respiratorsBelimed collaborating with 3M manufacturing see more
Courtesy of Lowcountry Biz SC
Can N95 respirators be decontaminated in a steam sterilization cycle for reuse in situations of severe personal protective equipment (PPE) shortage? That question has been explored through collaboration between a world-leading respirator manufacturer, 3M, and a global leader in sterilization solutions, Belimed.
“The expert team at 3M was open-minded and very supportive in evaluating this question,” says Markus Auly, Head of Scientific Affairs at Belimed. “After two rounds of testing six different respirator models steam-treated by Belimed, and a thorough technical analysis of the data, 3M felt confident in the compatibility of the process with certain respirator models.”
3M’s latest version of the Technical Bulletin confirms that one standard 250° F sterilization cycle in Belimed Medical Steam Sterilizer models MST-H or MST-V does not compromise the form, fit, and function of their flat-fold respirators.
The benefit of evaluating and confirming compatibility with this standard steam sterilization process is that it is the gold standard among decontamination technologies because of its high microbiocidal efficacy, even in the presence of residual soils. From a resource standpoint, it is safe to use due to freedom from toxic residues, easy to administer, and has low processing costs, using only water and electricity.
Steam decontamination of N95 respirators will double the availability of 3M flat-fold respirators during a supply crisis in any healthcare center that has a Belimed Steam Sterilizer MST-H or MST-V.
During the global shortage in the last months, the supply of N95 respirators in all regions of the world, including healthcare leaders like the USA, Germany, or the Netherlands, has been tight. It soon became clear that disposing of single-use respirators after one use (standard protocol) could leave health care workers exposed due to lack of supply.
Hospitals around the world are seeking options to provide respirators to their employees to help reduce their risk of exposure when working with confirmed or suspected COVID-19 patients. The solutions include extended use and/or contingency reprocessing methods, both of which have their challenges.
Previously, Belimed had published a white paper explaining these reprocessing options that various countries were adopting to alleviate the scarcity of disposable personal protective equipment (PPE) like N95 respirators, surgical gowns, or face shields. The goal was to share this information with healthcare facilities across the globe. The whitepaper can be downloaded on the Belimed website.
Now, with the evaluation by 3M of steam decontamination of N95 respirators, specific programmed cycles of the Belimed Steam Sterilizer MST-H or MST-V were determined to be compatible with specific 3M respirator models.
“Belimed’s number one priority has always been to protect the health and safety of hospital staff and their patients. With our expertise in sterile processing we want to contribute our part and create certainty in uncertain times,” says Dominik Arnold, CEO of Belimed. “Now our customers and the healthcare community can be confident to have a more reliable fall-back solution in times of short supply of N95 respirators.”
For more information please check 3M’s technical bulletin “Decontamination of 3M Filtering Facepiece Respirators, such as N95 Respirators, in the United States – Considerations” and Belimed’s website (www.belimed.com).
Belimed AG is a leading provider of product and service solutions for the sterilization, disinfection, and cleaning of medical and surgical instruments. The company, with its headquarters in Zug (Switzerland), can look back on more than 50 years of history. We are continuously developing our technology-based portfolio and are always looking for innovative solutions to improve reliability, efficiency and sustainability in sterile supply departments.
We are engineers of confidence: we listen to our customers and find the right solutions for their challenges. We create optimal conditions for a better working environment. Our comprehensive range of sterile workflow solutions ranges from planning and conception to industry-leading systems and consumables to professional services and data connection options. In addition, we offer our customers training and further education opportunities.
The focus of our work is the unlimited trust of our customers. Together we make an important contribution to medical progress and ensure the safety and health of patients and medical personnel.
Vikor Scientific featured in Charleston, Columbia and Greenville Business magazines see more
A number of South Carolina-based life sciences companies joined the battle against COVID-19 when the pandemic hit in early March. Prominent among this group is Charleston-based Vikor Scientific, a testing laboratory founded just over two years ago by entrepreneurs Shae Harrelson and Scotty Branch.
Vikor developed a COVID-19 test kit that is now widely used by nursing homes and other healthcare facilities across the nation. The test kit also tests for more than 40 other pathogens known to cause respiratory illness. Click to enjoy the entire article...
Company opens new manufacturing, quality control facilities see more
AmbioPharm Inc. a leading supplier of peptide active pharmaceutical ingredients has recently opened its new manufacturing and quality control facilities at its headquarters in South Carolina.
“The new buildings were completed in April and qualified by May 15, 2020 expanding our peptide manufacturing capacity,” stated Dr. Chris J. Bai, CEO. “The new buildings add nearly 56,000 sq. ft of production space to our current footprint in South Carolina. In the near future, our subsidiary site in Shanghai will also complete a new campus of 350,000 sq. ft. later this year.”
“As the world battles the Covid-19 pandemic, it has become increasingly apparent that no single solution will suffice for patients who are fighting the disease. Peptide approaches have been recently advanced for potential vaccine development, diagnostic testing and as therapeutic agents to help ameliorate the cytokine storm,” stated Dr. Michael W. Pennington, CSO. “Furthermore, we believe that science will prove to be the Achilles’ heel of the virus, and the world will recover more quickly as better therapies become available,” added Dr. Pennington.
AmbioPharm Inc. is uniquely positioned to help companies that are developing peptide-based approaches targeting the virus. As the company with the world’s largest cGMP peptide manufacturing capacity, AmbioPharm Inc. has a very unique business model which helps us to produce peptides of both high quality and purity with very economical cost. AmbioPharm Inc. can be contacted through our website if you have a project which requires our services.
COVID testing expands in workplace see more
As industry begins to reopen across the state, life science companies turn their sights to expanding COVID-19 diagnostic and antibody testing options for the workplace.
Greenville-based lab Precision Genetics partnered with Prisma Health in early April to process the health care system’s COVID-19 tests within 24-hours of reaching the lab.
Now that this testing line is fully automated with the capacity to churn out about 1,000 samples in a matter of hours, the lab is developing plans for the next testing battleground with a high-throughput COVID-19 diagnostic program called “Precision Worker Safety” and a smartphone employee wellness app created by Questis that uses an RFID thermometer to report feverish temperatures to employers.
“Up here in Greenville, manufacturing is a huge, huge part of our economic situation, so we have to be able to provide employers some kind of assurance that their employees can come back to work without a rapid spread of the virus,” Nate Wilbourne, CEO and president of Precision Genetics said, adding that it is “naive” to think the state peaked in mid-April with so little testing.
He said Precision is working with several large self-insured manufacturing companies as well as poultry suppliers to develop a salvia-based testing strategy. Pending a state-supported grant that the lab applied for during the week of May 1, Precision will launch saliva-based testing within three weeks.
Other methods of testing face a waiting period before they can be implemented, while the app is several months away from release, he said.
“What we’ve developed is a combination approach to COVID-19 screening and an antibody test as it evolves, as the workforce is building up an immunity at the individual level, which reduces the spread over time,” he said. “Until there’s a vaccine or some type of therapy, that is the safest way to go about this.”
In late April, however, Wilbourne said current antibody tests led to a number of false positives and negatives.
“Unfortunately, antibody testing is not very reliable today, as it sits,” he said. “There are still a lot of gaps in the science regarding the sensitivities and specifications. Right now, there are 50 proteins in the coronavirus. Right now, we (the health science community) are testing for multiple proteins, but there’s no way to guarantee which protein creates immunity.”
He also said antibody testing can only detect antibodies a few weeks after individuals have recovered from COVID-19 but noted that the work of professionals like Dr. John Wrangle, Precision’s chief medical officer and medical oncologist at the Medical University of South Carolina, are heading up research to broaden the window of antibody detection and accuracy of the tests.
Sam Konduros, CEO and president of SCBio, said the life sciences economic development network is working to support continued research and implementation of both diagnostic and antibody testing across the state.
“Even from the beginning, we were trying to present every approved and available COVID-19 test kit option we were aware of, and as you can imagine, we are moving heavily into the world of antibody testing now too,” he said. Our primary goal in representing the life sciences industry in the state is to have a very ecumenical approach of what resources are available that can help employers reopen as safely as possible if working remotely is not an option.”
One way SCBio hopes to open those options to employers is making test kits readily available to state industries through the COVID-19 Emergency Supply Collaborative that SCBio helped develop with the S.C. Manufacturers Extension Partnership, the S.C. Hospital Association and S.C. Department of Commerce.
Created in early April with the goal of bridging shortages in personal protective equipment and other critical needs goods to health care systems, Konduros said the online portal also welcomes purchases from businesses, especially manufacturers, in need of South Carolina-made masks, disinfectant, test kits or a host of other high-demand products.
On April 7, Konduros also noted that antibody testing tended to be a less reliable indicator than diagnostic testing at this point, but he sees potential for companies to use both, especially as antibody testing becomes more sophisticated and “herd immunity” builds.
“From a diagnostic standpoint, there doesn’t seem to be a substitution for PCR testing, which is going to be the one way to confirm a diagnosis for someone with COVID-19, either someone who is showing acute symptoms or has had clear exposure, or is working in an environment where an employer would simply need to know there is that issue,” he said.
On the other hand, Konduros is intrigued by the potential of workforce antibody testing as research moves forward, especially with tests used by Abbott Laboratories, that detect IgG antibodies that remain in the bloodstream for several weeks after an individual recovers from COVID-19. He said that as the state moves into summer, Abbott is planning to release large quantities of IgG tests that are at least 98% accurate.
“I certainly think the antibody tests are going to innovate and improve over time, and there’s going to be a lot more data to see how people are responding who have had COVID-19 and what kind of immunity is being developed. There are just so many variables right now,” Konduros said.
South Carolina firm's NP Collection Swab offers a highly scalable injection-molded design see more
South Carolina-based Hoowaki LLC has developed an innovative one-piece injection molded design for a COVID-19 swab to help close the gap in U.S. and global COVID-19 testing supplies. The 12-year old micro surface engineering and product solutions company has adapted its proprietary HOOWAKI MICROGRIP® surface technology to create micro-pillars used in the Hoowaki® NP Collection Swab that is shown in clinical user testing to meet existing industry-standard products for flexibility and performance. In independent laboratory testing (qPCR Assay) it has also been proven to be equivalent to the industry-standard flocked filament swabs in the collection of patient RNA that is critical for COVID-19 testing. Mass-production of its FDA registered, patent pending, Hoowaki® NP Collection Swab will begin this summer and is expected to reach at least several million units per month.
"The Hoowaki® NP Collection Swab is an important answer to the challenges posed by the global COVID-19 pandemic," said Ralph Hulseman, president of Hoowaki LLC. "Our design allows for production to be quickly scaled in communities around the world—rapidly addressing the rising demand for swabs, a critically important element of all COVID-19 testing."
A recent study by Harvard University [https://ethics.harvard.edu/files/center-for-ethics/files/roadmaptopandemicresilience_updated_4.20.20_0.pdf] cites the need for up to 20 million COVID-19 tests per day by the end of summer. The proprietary Hoowaki® NP Collection Swab is manufactured using advanced injection molding technologies that utilize existing equipment that is readily available in communities throughout the world. The swab's scalability is due to Hoowaki LLC's formulations and engineering designs working at existing injection molding facilities, which enables the swab to be produced in quantities that meet local demands anywhere in the world.
"Prisma Health collaborated with Hoowaki LLC in the testing and development of the innovative new design. The soft feel and ease of use of the Hoowaki® NP Collection Swab tip impressed my team," said Jennifer Meredith, Ph.D., clinical microbiology director at Prisma Health-Upstate.
"Prisma Health is excited to see a locally produced solution that could help ease the shortage of swabs for COVID-19 sample collection," said Meredith. "Hoowaki LLC's product has the potential to help us meet our commitment to our patients in the fight against COVID-19." Prisma Health, the largest healthcare system in South Carolina, harnessed its Rapid Innovation Task Force to help with the project.
Hulseman credits several public-private partnerships that have helped to provide start-up funding for the swab's development: "As is the case for many businesses in today's environment, Hoowaki LLC adapted quickly to meet new challenges where demand is outpacing supply so we could remain not only viable as a company, but also pursue this pioneering technology. We're grateful for the backing of the Greenville Local Development Corporation (GLDC) and SC Launch, Inc., an investment affiliate of the South Carolina Research Authority (SCRA), who have been instrumental in helping us develop the Hoowaki® NP Collection Swab."
"Hoowaki LLC is a great example of a small business that has proven to be a powerhouse of innovation during a time of incredible challenge," said David Barnett, Chairman of the Greenville Local Development Corporation. "We are proud of our continued support for Hoowaki LLC in the development of the NP Collection Swab."
Hoowaki, LLC is a micro surface engineering services and product solutions company that has developed unique micro surface pattern designs, engineering algorithms, software and manufacturing know-how to address major markets. The company's micro surface technology provides grip or slip solutions in the form of films for medical devices, packaging and other industrial and consumer products. Their team includes experienced micro surface engineers, physicists, friction experts, medical device experts, entrepreneurs, inventors and developers. Hoowaki has market deployment partnerships with Havi (packaging) and BvW Holding AG (implanted medical devices). Hoowaki has a broad patent coverage of micro surface technology.
Nephron announces new partnership see more
Nephron Pharmaceuticals Corporation, one of the fastest growing pharmaceutical companies in the country, announced a new partnership with One Medical, a leading national digital health and primary care organization that combines 24/7 access to virtual care and digital health tools with COVID-19 testing services to businesses and employees.
“Re-opening businesses, and getting our economy moving again, is one of our highest priorities,” said Nephron CEO Lou Kennedy, who is a member of Governor Henry McMaster’s #accelerateSC, the coordinated COVID-19 advisory team tasked with recommending economic revitalization plans for South Carolina. “Part of the new normal for businesses is testing employees to make sure the workplace is safe. We couldn’t be prouder to offer COVID-19 testing services to our employees and neighbors.”
Kennedy and John Singerling, Chief Network Officer of One Medical and a longstanding healthcare executive based in South Carolina, are working together to make this partnership a reality, hoping that it serves as an example for businesses around the country.
The Nephron CLIA-Certified lab has procured state-of-the-art technology for COVID-19 real-time PCR testing and serological antibody testing for its own employees, and for employees of neighboring businesses. The lab intends to integrate with One Medical’s technology platform, which is capable of supporting a comprehensive workplace reentry COVID-19 testing program. One Medical’s virtual care solutions facilitate scheduling for specimen collection and digitally documenting those test results. It also screens and evaluates clinical risk factors and symptoms and supports employer tracking and reporting needs.
“I am very pleased to be working alongside the Nephron team to leverage One Medical’s digital health platform as a way to help get South Carolinians back to work safely,” said One Medical Chief Network Officer, John Singerling. “Currently working with over 7,000 employers nationwide has allowed One Medical to build a comprehensive workplace reentry program that is grounded in medicine and testing, and powered by our technology, which allows for seamless tracking, tracing and ongoing monitoring.”
SARS-CoV-2 PCR tests diagnose whether a person is infected with the virus by using technology that analyzes viral genetic material. Antibody tests check blood for antibodies. If present, antibodies indicate a person has been previously or is currently infected by the virus.
Nephron Pharmaceuticals Corporation has been on the frontlines of the nationwide COVID-19 response. The West Columbia-based company develops and produces safe, affordable generic inhalation solutions and suspension products that can be used to treat severe respiratory distress symptoms associated with COVID-19. In addition, the company operates an industry-leading 503B Outsourcing Facility division which produces pre-filled sterile syringes and IV bags for hospitals across America, in an effort to alleviate their drug shortage needs. These products are used, many times, to sedate patients and keep them comfortable when health care professionals place them on ventilators in the fight against the virus.
Clemson targets fix for mask shortage see more
(Courtesy, Paul Alongi, Clemson College of Engineering, Computing and Applied Sciences)
Melinda Harman of Clemson University is volunteering her time to explore how hospitals could wash and sanitize medical masks without having to ship them elsewhere or buy an expensive piece of equipment.
A device that Harman designed to hold multiple N95 masks is central to her idea. It would help ensure the masks maintain their shape while being washed so that they continue to fit securely around the mouth and nose, said Harman, an associate professor of bioengineering and director of Clemson University’s Medical Device Recycling and Reprocessing program, or GreenMD.
The masks help prevent healthcare workers from inhaling the novel coronavirus that causes COVID-19 and have been in short supply since the pandemic began.
As part of her work, Harman said she has engaged three leading healthcare companies that offer expertise in detergents and decontamination. She is testing different kinds of detergents to find the best solution for cleaning mucus and proteins from the masks.
The detergents are commercially available and already used by hospitals to clean other types of medical equipment.
Harman said that her goal is “to validate a cleaning process that is compatible with existing capabilities and equipment commonly available at hospitals in South Carolina and worldwide.”
The challenge is “to avoid interfering with mask performance, while effectively cleaning the masks without degrading their filtering capacity,” she said.
Harman added, “Working with innovative industry partners is a considerable advantage, with everyone on the team willing to contribute a potential solution. They are providing reliable products that are already proven to meet routine reprocessing challenges in healthcare delivery.”
Harman said one of the advantages to her approach is that many hospitals already have the ability to clean medical equipment, even if they aren’t yet applying it to the masks. That means hospitals wouldn’t need to buy any capital equipment, she said.
Further, the masks would stay at the hospital, reducing travel time, the risk of spreading contamination outside of the hospital and the additional burden on an already-stressed logistics system, Harman said.
“The technology I’m working on is meant to be used broadly, compatible with existing reprocessing practices that are already in hospitals,” Harman said. “It’s intended for rapid deployment in health care settings, and it’s meant to be compatible with any sterilization system.”
Harman added, “Cleaning masks before sterilization enables more masks to be reused Right now, guidelines for sterilization require N95 masks to be inspected and discarded if they are ‘soiled.’ My idea is to reliably clean masks to remove both the visible and ‘invisible’ soils, making the entire reuse process safer.”
Martine LaBerge, chair of the Department of Bioengineering, said that Harman is well qualified to lead the work.
Harman has conducted extensive research into reuse and reprocessing of medical equipment. As director of GreenMD, she engages students in industry-driven research targeting healthcare needs in South Carolina and broader global health challenges. GreenMD is the nation’s only engineering-focused program for medical device design targeted for reprocessing and reuse.
“Dr. Harman has built a career on developing innovative ways to reprocess and reuse medical equipment that is normally disposable, which uniquely positions her to have a global impact,” LaBerge said. “I thank her for her service to South Carolina, the nation and the globe as we join together in the face of the unprecedented challenges posed by COVID-19.”
Harman said that if her idea works, used masks would be sent to central sterilization facilities within hospitals. The device she designed would hold the masks while they are cleaned. After cleaning, the masks would go through a separate sterilization process to get rid of any lingering microorganisms, including coronavirus.
The mask-holder that Harman designed could be 3D-printed, she said. However, she is focusing on more rapid manufacturing approaches using common acrylic materials. The technology could be readily adapted in hospitals from South Carolina to India, Harman said.
She recently disclosed the technology to the Clemson University Research Foundation, setting it on the path to commercialization and raising the potential for widespread use.
Harman said what’s been most interesting to her is that her previous work with resource-poor countries has come home to the United States, with disrupted supply chains and inadequate supplies at the point of need.
“That’s exactly the situation we’ve been working on with other countries,” Harman said. “For me that’s just been a startling change. It’s been amazing to see how many people have become interested in the topic of safe and sustainable reuse and how many unique solutions they come up with. I hope that creative energy continues, because it can solve a lot of global health problems.”
Nephron gets nod from FDA see more
West-Columbia headquartered-Nephron Pharmaceutical Corp.’s fight against the COVID-19 pandemic has received an additional weapon.
The Food and Drug Administration approved the company’s request to add a production line used in the manufacturing of bronchodilator albuterol today, Nephron CEO Lou Kennedy told the Columbia Regional Business Report.
“This news came in 20 minutes ago,” Kennedy said Monday morning. “People are cheering. It’s like The Price is Right or something.”
Kennedy said she expects to hear whether a second production line has been approved later this week.
Last month, Kennedy petitioned the FDA to add up to six production lines moved to Columbia from the company’s previous Florida headquarters in 2019. Kennedy said the additional lines could help the sterile respiratory medication manufacturer keep up with unprecedented demand.
Kennedy said March saw a 141% increase in the doses of inhalation solutions Nephron typically produces a month.
“We went from a regular month of about 80 million shipped to 193 million shipped in March. That’s just for the respiratory side,” she said. “For our sterile injectable medications that we make for all the hospitals in America that have drug shortage needs, that was up by like 22%. We’re seeing the same exact trend in April.”
Kennedy praised the FDA for its quick response, saying the federal agency granted Nephron a CBE-30, “which means Change Being Effected. That’s giving you a goal date of 30 days or less to review your material and be able to say yes or no,” she said.
“That’s really something. You’ve just got to know and feel good as a patient or a potential patient in America that the FDA has been working with me on the phone almost every day, or by email, trying to get this through expeditiously so that we can crank up a few more lines.
“As much as we can make, we’re selling. I don’t want to get behind. So if we can get these other lines approved pretty quickly, then we’ll be able to pump out — if I get four lines, at least another 50 million a month.”
Also helping meet demand, Kennedy said, are the efforts of the S.C. Ports Authority.
Last Thursday, four gigantic containers of automated packaging equipment arrived at Nephron headquarters from Switzerland. Today, the company is expecting air delivery of critical supplies from Italy, one of the countries hardest-hit by the COVID-19 pandemic.
“You know how difficult that was to pull off?” Kennedy said.
Kennedy developed a working relationship with the port as she moved hundreds of millions of dollars in equipment from Florida to West Columbia when Nephron relocated to South Carolina in 2014. During her time as chair of the S.C. Chamber of Commerce from 2018-19, Kennedy came to know S.C. Ports CEO Jim Newsome and COO Barbara Melvin well.
Expecting last week’s shipment of automated equipment to help Nephron workers quickly label, package and ship products, Kennedy called Melvin.
“I reached out to see what the situation was going to be like in getting these pieces of equipment,” she said. “That equipment, which was four giant containers, arrived to the dot at 9 a.m. (Thursday) morning all because of two great South Carolina partners — UPS and its hub that’s located one exit from me, and the Ports Authority.
“All of these drugs that are packaged will go to benefit speedier to-market products for patients with COVID-19. … This is front-line equipment that we need to get our products to market quicker.”
Nephron is also gearing up to begin releasing 100-mL saline bags for administration of sodium chlorine. The minibags, made scarce after the 2017 hurricane season hit manufacturer Baxter Healthcare hard, are once again in short supply, Kennedy said.
“We are very happy to say that we’ve been producing 100-mL saline for the last two weeks in anticipation for this going on shortage,” said Kennedy, who said the bags would be released this past Friday.
While Nephron has ramped up production in response to previous respiratory illnesses such as SARS and H1N1, Kennedy said the COVID-19 crisis is unlike anything she’s ever seen. Nephron began making its own hand sanitizer last month, distributing 50 liters to the William Jennings Bryan Dorn Veteran Affairs Center.
“I had absolutely no idea we’d reach these levels. I couldn’t even imagine, can’t even imagine, still am trying to process,” Kennedy said. “One particular day, two or three weeks ago, one hospital system in New York ordered 3,000 nebulizers from us. A typical thing might be 50, no more than 100. They ordered 3,000.”
S.C. Ports and other transportation partners have helped Nephron fill the exploding demand, Kennedy said, while Nephron workers are proud to be playing a role in combating the virus.
“I couldn’t even begin to compare ourselves with what they’re doing at hospitals, but there is a true sense of patriotism,” she said. “People are coming to work optimistic in the fact that they’re helping, in their own small way, American patients.”
Veravas partners to develop test see more
True Diagnostics, Inc. (TrueDx), a leading Point of Care (POC) company, Infectolab Americas (Infectolab), a recently established CLIA laboratory specializing in comprehensive testing for tick-born infection, and Veravas, Inc. (Veravas), an emerging diagnostic company focusing on proprietary sample preparation products and new diagnostic tests, announced today their Strategic Alliance to develop and commercialize VeraTest™ SARS-CoV-2 IgA/IgG Rapid Test. This novel POC test will utilize the TrueDX Platform™, Infectolab's COVID-19 serology testing services and infectious disease expertise,and Veravas' patent pending VeraPrep™ clean and VeraPrep™ capture technologies to remove cross-reacting antibodies to other coronaviruses while only binding and detecting antibodies specific to SARS-CoV-2. Serology testing makes population screening possible, including screening of people who were never diagnosed, either because they didn't feel particularly sick or they couldn't get an initial test. VeraTest™ SARS-CoV-2 IgA/IgG Rapid Test will play an important roll in understanding COVID-19 and the epidemiology of this coronavirus.
VeraTest™ SARS-CoV-2 IgA/IgG Rapid Test will provide a digital qualitative answer in less than 15 minutes to determine if antibodies against COVID-19 have been detected in the blood. IgM and IgA provide the first line of defense during viral infections, followed by the generation of adaptive, high-affinity IgG responses for long-term immunity and immunological memory. The detection of COVID-19 IgA antibodies tends to indicate a recent exposure to COVID-19 and is more specific for COVID-19 in lung tissues and mucosal surfaces, and detection of COVID-19 IgG antibodies indicates a later stage of infection, so this combined antibody test could also provide information on the stage of the disease in patients. Current guidance from the U.S. Food and Drug Administration (FDA) recommends that results from antibody testing should not be used as the sole basis to diagnose or exclude coronavirus infection. Depending on the clinical scenario, additional testing, such as with VeraTest™ COVID-19 IgA/IgG Rapid Test, may be considered to further evaluate the possibility of SARS-CoV-2 infection.
"In these challenging times, True Diagnostics, Inc. is proud to be part of this alliance to help expedite critical solutions that can help provide the needed specificity, performance, scalability, and simplicity to market," stated Jerry Lee, CEO and President of True Diagnostics. "Veravas is quickly emerging as the leader in raising the standard of care in laboratory medicine and we look forward to co-developing tools that are essential to support the IVD market and improving the lives of so many patients."
"A collaboration between Infectolab Americas and Veravas is the logical consequence for our two Minnesota companies. We are complementary to each other and have a lot of synergy. We will use this to achieve something that is desperately needed in this time of testing crisis. We will strive to deliver a high quality test for SARS-CoV-2 that is more accurate and sensitive than any other test on the market," said Felix Scholz, President of Infectolab Americas.
"This strategic alliance with TrueDx utilizing their TrueDX Platform™, along with Infectolab's CLIA lab validation capabilities and infectious disease expertise, will allow Veravas to quickly develop a POC test that's easy to use and displays results in under 15 minutes. We are confident that the combined efforts of our three companies will result in the successful development of a rapid test that will assist healthcare providers and laboratorians to quickly and reliably determine whether a patient has developed antibodies to the COVID-19 virus. Most importantly, it will identify those individuals who can safely return to work and go about their daily lives," said Carroll E. Streetman Jr., Chief Executive Officer of Veravas.
TrueDx and Veravas continue to collaborate and expand their portfolios with other emerging organizations and institutions to bring diagnostic solutions and products like VeraTest™ to market.
About True Diagnostics
True Diagnostics (TrueDx) designs and develops innovative POC diagnostic tests and devices based on its proprietary TrueDX™ Platform, which utilizes reliable and low-cost lab methods and its own proprietary or partnered biomarkers to offer rapid diagnoses to facilitate treatment decisions in point-of-care, point-of-incidence and remote-of-care settings. The TrueDX Platform's portability and affordability allow it to be easily adopted into emerging markets to provide accurate diagnosis within minutes. For the $21 billion point-of-care market, the power of the TrueDX Platform lies in its simplicity and flexibility. Tests have an 18-month or longer shelf life with no refrigeration required. The platform's flexible design additionally permits it to quickly commercialize a myriad of biomarkers discovered for cancer, autism, Alzheimer's, diabetes, drugs of abuse, infectious diseases, cardiac health, traumatic brain injury, viral and bacterial infections and more.
About Infectolab Americas
Infectolab Americas is a recently established laboratory located in Oakdale, Minnesota, specializing in comprehensive lab testing for tick-borne infections which provides the tools necessary for Health Care Practitioners to diagnose tick-borne diseases. Their focus is on delivering a quality laboratory performance and guaranteeing a superior sample output; this entails quick shipping time and a rapid turnaround time, as well as providing the most accurate laboratory results possible.
Veravas is transforming laboratory medicine with technology that delivers superior test results, providing confidence to clinicians and patients that diagnoses are accurate. The company's R&D facilities are based in Oakdale, Minnesota, and our staff of scientists and business development are rapidly driving the commercialization of proprietary sample preparation products and new diagnostic tests. Veravas' nanomagnetic particles can identify, remove, and measure select substances from patient samples to reduce the effects of complex interferences and detect low-abundance biomarkers. Led by a passionate and dedicated team, Veravas is devoted to improving patient lives by minimizing the harmful effects of unnecessary treatments and deaths associated with poor quality diagnostic results. Because every patient deserves the correct result, every time. Please visit us at www.veravas.com
Precision Genetics receives SCRA grant see more
SCRA announces a $250,000 SC Launch, Inc. investment in Precision Genetics. The life sciences company, located in Greenville, was recently accepted into SCRA’s entrepreneurial program, SC Launch.
Precision Genetics validated the Emergency Use Authorization (EUA) via the Food and Drug Administration (FDA) to process COVID-19 test kits. Precision Genetics is now available to support state and local healthcare systems in need of public health surveillance, and has priority access to test reagents from commercial reagent manufacturers, which have received EUA from the FDA.
Precision Genetics provides the test kits for healthcare facilities and providers looking to test patients using real-time RT-polymerase chain reaction (RT-PCR) detection of the SARS-CoV-2 virus (the virus that causes COVID-19) in respiratory specimens. The test uses RT-PCR to detect the virus in upper and lower respiratory specimens.
Currently, results will be available within 24 hours (one business day) from time of receipt of the sample in the laboratory, with plans to boost testing capacity in the coming week. Precision Genetics’ healthcare technology laboratory has the capability to direct-connect to other laboratories, healthcare systems, and practitioners’ offices to deliver test information within seconds of the results being reported. The laboratory uses a cloud-based information system, Ovation.io, to help expedite the test orders, specimen tracking, and results to support faster response times to the COVID-19 pandemic.
In addition to COVID-19 testing, Precision Genetics uses an advanced scientific approach to treating employees and patients, using healthcare data to determine the risks associated with medications and complex drug regimens. By combining genetic markers, molecular data, and clinical evidence into a comprehensive and actionable solution, they allow providers to immediately develop individualized treatment and prevention plans for their patients.
“Healthcare facilities throughout South Carolina were struggling to find COVID-19 test facilities that could provide both accurate and timely results”, said Steve Johnson, SCRA Investment Manager. “Some institutions were waiting eight days or more before receiving results. Other testing services were no longer even accepting any further samples. It was critical that an experienced South Carolina-based lab have the throughput capacity to handle the volume of COVID-19 testing that was predicted to be coming. Because of Precision Genetics’ existing track record of providing excellent advanced molecular testing and innovative solutions to healthcare institutions in the state, SCRA and SC Launch, Inc. are proud to provide this investment to Precision Genetics at a time when their capabilities are critically needed in our state.”
“This national and statewide pandemic has challenged us as business leaders to create immediate solutions on behalf of our patients and healthcare providers. The challenge in South Carolina is that we lack sufficient laboratory infrastructure to deploy testing solutions in rapid form in order to manage the immenent demand that our state requires. All labs face a similar obstacle of obtaining the necessary resources and supplies to accommodate our patient volumes. SCRA and SC Launch, Inc. stepped up and provided financial commitment and strategic support for us to expedite our efforts. We are desperately trying to serve our community in this time of need, and we are very grateful for the support from SCRA and SC Launch, Inc.” said Nate Wilbourne, CEO of Precision Genetics.
SCRA is a state-chartered organization that fuels job creation and grows South Carolina’s innovation economy. Through SCRA’s programs, early-stage companies are provided mentoring and grants and may be eligible for an investment from SCRA’s investment affiliate, SC Launch, Inc.